U.S. Department of Health and Human Services
Public Health Service

SF424 (R&R)
Application Guide
for NIH and Other PHS
Agencies
A guide developed and maintained by NIH for preparing
and submitting applications via Grants.gov to NIH andother PHS agencies using the SF424 (R&R)
Forms Version C application packages
Updated July 25, 2013

PHS SF424 (R&R) Forms Version C Application Guide

TABLE OF CONTENTSPART I. INSTRUCTIONS FOR PREPARING AND SUBMITTING AN APPLICATION
1. Foreword ............................................................................................................................................... 1
1.1
1.2
1.3
1.4
1.5
1.6
1.7
1.8

Application Guide Format ............................................................................................................ 3
NIH Extramural Research and Research Training Programs ....................................................... 4
Research Grant Activity Codes and Program Guidelines ............................................................. 4
Interactions with PHS Staff .......................................................................................................... 5
Grants Policy Statements .............................................................................................................. 8
References .................................................................................................................................... 8
Authorization .............................................................................................................................. 10
1.7.1
Collection of Personal Demographic Data................................................................... 10
Paperwork Burden ...................................................................................................................... 10

2. Process for Application Submission via Grants.gov........................................................................ 11
2.1
2.2

Overview .................................................................................................................................... 11
Registration Processes ................................................................................................................ 12
2.2.1
Grants.gov Registration ............................................................................................... 12
2.2.2
eRA Commons Registration ........................................................................................ 12
2.3 Software Requirements............................................................................................................... 15
2.3.1
Adobe Reader............................................................................................................... 15
2.3.2
Creating PDFs for Text Attachments ........................................................................... 15
2.3.3
Special Instructions for Macintosh Users .................................................................... 15
2.4. Funding Opportunities ................................................................................................................ 16
2.4.1
NIH Guide for Grants and Contracts ........................................................................... 16
2.4.2
Funding Opportunity Announcements ......................................................................... 16
2.4.3
Finding a Funding Opportunity Announcement (FOA) for Grants.gov Submission ... 17
2.5 Forms for an Application to NIH or Other PHS Agencies ......................................................... 20
2.6 Format Specifications for Text (PDF) Attachments ................................................................... 22
2.7 “Resubmission” Applications ..................................................................................................... 24
2.8 “Revision” Application............................................................................................................... 26
2.9 Similar, Essentially Identical, or Identical Applications ............................................................ 26
2.10 Submitting Your Application Via Grants.gov ............................................................................ 27
2.11 After You Submit Your Application Via Grants.gov ................................................................. 28
2.12 Correcting Errors ........................................................................................................................ 30
2.13 Post-Submission Application Materials ..................................................................................... 32
2.14 Application Submission Dates.................................................................................................... 34
2.15 Submission, Review and Award Cycles ..................................................................................... 35
2.16 Resources for Finding Help ........................................................................................................ 36
2.16.1 Finding Help for Grants.gov Registration or Submissions .......................................... 36

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2.16.22.16.3Finding Help for the eRA Commons Registration or eRA Commons Validation
Processes ...................................................................................................................... 37
Finding Help for Application Preparation ................................................................... 38

3. Using the Grant Application Package .............................................................................................. 38
3.1
3.2
3.3
3.4
3.5

Verify Grant Information............................................................................................................ 38
Enter the Name for the Application ............................................................................................ 39
Open and Complete Mandatory Documents............................................................................... 39
Open and Complete Optional Documents .................................................................................. 39
Submitting the Application via Grants.gov ................................................................................ 40

4. Completing the SF424 Research and Related (R&R) Forms ......................................................... 40
4.1
4.2
4.3
4.4
4.5
4.6
4.7

4.8

Overview .................................................................................................................................... 40
Cover Form ................................................................................................................................. 41
Project/Performance Site Locations Form .................................................................................. 57
Other Project Information Form ................................................................................................. 61
Senior/Key Person Profile (Expanded) Form ............................................................................. 68
Selecting the Appropriate Budget Form ..................................................................................... 77
R&R Budget Form...................................................................................................................... 78
4.7.1
Section A and B ........................................................................................................... 78
4.7.2
Sections C through E ................................................................................................... 84
4.7.3
Sections F through K ................................................................................................... 86
4.7.4
Cumulative Budget ...................................................................................................... 91
Special Instructions for Preparing Applications with a Subaward/Consortium ......................... 93

5. Completing PHS 398 Form ................................................................................................................ 97
5.1
5.2
5.3
5.4

5.5
5.6
5.7
5.8

Overview .................................................................................................................................... 97(Reserved)................................................................................................................................... 98
Cover Page Supplement Form .................................................................................................... 98
Modular Budget Form .............................................................................................................. 103
5.4.1
Budget Period Form ................................................................................................... 105
5.4.2
Cumulative Budget Information ................................................................................ 107
PHS 398 Research Plan Form................................................................................................... 109(Reserved)................................................................................................................................. 120(Reserved)................................................................................................................................. 120
Planned Enrollment Report and Cumulative Inclusion Enrollment Report.............................. 120
5.8.1 Planned Enrollment Report.............................................................................................. 121
5.8.2 Cumulative Inclusion Enrollment Report ........................................................................ 123

6. Peer Review Process ......................................................................................................................... 126
7. Supplemental Instructions to the SF 424(R&R) for Preparing an Individual Research Career
Development Award (CDA) Application (“K” Series) ................................................................. 130
7.1

Introduction .............................................................................................................................. 130

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7.2
7.3
7.4

7.5
7.6

Individual Career Development Award Programs.................................................................... 130
Letters of Reference (must be submitted electronically through the eRA Commons) ............. 131
K- Specific Instructions for K Applications using the SF424 (R&R) Application .................. 134
7.4.1
Special Instructions for 4.2 Cover Form .................................................................... 134
7.4.2
Special Instructions for 4.3 Research & Related Project/Performance Site Locations
Form ........................................................................................................................... 134
7.4.3
Special Instructions for 4.4 Other Project Information Form ................................... 134
7.4.4
Special Instructions for 4.5 Senior/Key Person Profile(s) Form................................ 135
7.4.5
Special Instructions for 4.6 Selecting the Appropriate Budget Form ........................ 138
7.4.6
Special Instructions for 4.7 R&R Budget Form ......................................................... 138
7.4.7
Special Instructions for 5. Completing PHS 398 Forms ........................................... 139
PHS 398 Career Development Award Supplemental Form ..................................................... 140
Career Development Award Peer Review Process ................................................................... 160

8. Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein
National Research Service Award (NRSA) Application ............................................................... 161
8.1
8.2
8.3
8.4

8.5
8.6
8.7
8.8

Introduction .............................................................................................................................. 161
Institutional Research Training Programs ................................................................................ 162
Reserved ................................................................................................................................... 162
Specific Instructions for Institutional Training Grant Applications using the SF424 (R&R)
Application ............................................................................................................................... 162
8.4.1
Special Instructions for 4.2 Cover Form .................................................................... 162
8.4.2
Special Instructions for 4.3 Research & Related Project/Performance Site Locations162
8.4.3
Special Instructions for 4.4 Research & Related Other Project Information Form ... 162
8.4.4
Special Instructions for 4.5 Senior/Key Person Profile (Expanded) Form ................ 164
8.4.5
Special Instructions for 4.7 Research & Related Budget ........................................... 165
8.4.6
Special Instructions for 4.6 PHS 398 Cover Page Supplement ................................. 165
PHS 398 Training Budget......................................................................................................... 165
PHS 398 Training Subaward Budget Attachment(s) Form ...................................................... 171
Research Training Program Plan Form .................................................................................... 174
Training Grant Peer Review Process ........................................................................................ 189

9. Supplemental Instructions to the SF 424 (R&R) for Preparing a Multi-Project Application .. 190
9.1
9.2
9.3
9.4

Introduction .............................................................................................................................. 190
Multi-Project Applications ....................................................................................................... 190
9.2.1
Collaborating with Other Organizations .................................................................... 191
Application Submission System & Interface for Submission Tracking (ASSIST) .................. 191
Special Instructions to the SF424 R&R for Multi-Project Applications .................................. 193
9.4.1
Special Instructions for 4.2 Cover Form .................................................................... 193
9.4.2
Special Instructions for 4.3 Project/Performance Site Locations............................... 194
9.4.3
Special Instructions for 4.4 Other Project Information Component .......................... 194
9.4.5
Special Instructions for 4.5 Senior/Key Person Profile (Expanded) .......................... 196
9.4.6
Special Instructions for 4.7 R&R Budget .................................................................. 197

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9.4.7
9.4.8

SF424(R&R)

Special Instructions for 5.3 PHS 398 Cover Page Supplement ................................. 197
Special Instructions for 5.5 PHS 398 Research Plan ................................................. 198v

PART I
Instructions for Preparing and Submitting
an Application

PHS SF424 (R&R) Adobe Forms Version C Application Guide

1.

Foreword

Forms Version C Application Guide — Released July 25, 2013This application includes changes to SF424 Research & Related (R&R) form instructions necessitated by
the OMB renewal and Grants.gov’s subsequent release of updated forms in June 2013. Changes have also
been made to various PHS 398 forms and instructions approved by OMB in August 2012 and released by
Grants.gov in June 2013. Parts II (Supplemental Instructions for Preparing the Human Subjects Section of
the Research Plan) and III (Policies, Assurance, Definitions, and Other Information) of the previous
version of the application guide have been moved to a stand-alone document titled, “Supplemental Grant
Application Instructions.”
Modifications include the following:
SF424 (R&R) Forms
System for Award Management (SAM) Registration•

A change from the requirement to register with the Central Contractor Registry Database (CCR)
to the System for Award Management (SAM).

SF424 (R&R) Cover Form•

A new field for the “Previous Grants.gov Tracking ID” is included. Form behavior will be
adjusted so that applications with Submission Type of “Change/Corrected Application” require
an entry in the “Previous Grants.gov Tracking ID” field rather than requiring an entry in the“Federal Identifier” field.

•

The Person to be contacted section of the Applicant Information has expanded to include theadditional contact information we have been including on the PHS 398 Cover Page Supplement
form. The additional contact information has been removed from the PHS 398 Cover Page
Supplement.

•

The label for the “SFLL or other Explanatory Documentation” has been changed to “SFLLL(Disclosure of Lobbying Activities) or other Explanatory Documentation.”•

A new “Cover Letter Attachment” has been added and a separate PHS Cover Letter form will nolonger be used. However, NIH will continue to keep the Cover Letter separate from theassembled application image and available only to authorized staff.

SF424 (R&R) Budget Form•

The cumulative Number of Participants/Trainees allowed on the SF424 (R&R) budget form andassociated Subaward Budget forms has been expanded from 999 to 9999 to address a form bug.
On previous form versions, maxing out the Number of Participants/Trainees on all budget periods
caused an application to fail because the forms didn’t allow a bigger number for the cumulative
total.

SF 424 (R&R) Sr/Key Person Expanded Form•

The number of Sr/Key Persons that can be entered has been expanded from 40 to 100.

SF 424 (R&R) Project Performance Site Locations Form•

The number of Performance Sites that can be entered has been expanded from 30 to 300.

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PHS 398 Forms
Planned Enrollment Report Form & PHS 398 Cumulative Inclusion Enrollment Report Form•

Added optional inclusion forms in application packages to allow for the collection as discrete datarather than .pdf attachments.

•

Removed enrollment and inclusion attachment fields from PHS 398 Research Plan, PHS 398
Career Development Award Supplemental Forms.

PHS 398 Career Development Award Supplemental Form•

Removed “Application Type” section.

•

Removed “Career Development Award Attachment” header.

•

Removed Inclusion and Enrollment attachments (now separate forms in the application package).

•

Added a new attachment for “Letters of Support from Collaborators, Contributors, andConsultants.”•

Renamed attachment from “Career Development/Training Activities During Award Period” to“Candidate’s Plan for Career Development/Training Activities During Award Period.”•

Renamed attachment from “Mentoring Plan” to “Candidate's Plan to Provide Mentoring (asapplicable).”•Changed section header from “Statements of Support” to “Statements and Letters of Support.”•

Made adjustments to format and numbering.

PHS 398 Research Plan Form•

Removed “Application Type” section.

•

Removed “Research Plan Attachment” header.

•

Removed Inclusion and Enrollment attachments (now separate forms in the application package).

•

Made adjustments to format and numbering.

PHS 398 Training Program Plan Form•

Removed “Application Type” section.

•

Removed “Research Training Program Plan Attachment” header.

•Renamed attachment field from “Introduction to Application (for REVISION or
RESUBMISSION applications only)” to “Introduction to Application (for RESUBMISSION or
REVISION only).”•

Made adjustments to format and numbering.

PHS 398 Training Subaward Budget Attachment Form•

Limit of subaward budget attachments has increased from 10 to 30.

PHS 398 Cover Page Supplement Form•

Removed Applicant Organization Contact information that will be included on SF424 R&R
Cover Form.

•

Added fields from PHS 398 Checklist form. The separate PHS 398 Checklist Form will nolonger be used.

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Limit of collection of human embryonic stem cell lines has increased from 20 to 200.

•

Made adjustments to format and numbering.

Notes
This version of the Application Guide now also includes a separate instruction section for multicomponent applications to accommodate their transition to electronic submission effective withsubmissions on/after September 25, 2013.
For additional details on all the form changes noted above, see NIH Guide Notice NOT-OD-13-074.
This application guide contains instructions and other useful information for preparing grant applications
to the National Institutes of Health (NIH) and other Public Health Service (PHS) agencies for:Public Health Service (PHS) Research Grants
Career Development (K) Awards
Institutional Training (T) Grants
Supplemental Instructions to the SF424 (R&R) for Preparing a Multi-Project Application
This application guide is used as a companion document to the SF424 Research and Related (R&R)
application forms. In addition to the SF424 (R&R) forms, applications to NIH and other PHS agencies
will include agency-specific forms, titled “PHS 398.” These PHS 398 forms were developed to continue
the collection of agency-specific data required for a complete application. While these agency-specificforms are not identical to the PHS 398 application form pages, the PHS 398 reference is used to
distinguish these additional data requirements from the data collected in the SF424 (R&R) forms. A
complete application to NIH and other PHS agencies will include SF424 (R&R) forms and PHS 398
forms. Instructions for all application forms, SF424 (R&R) and PHS 398, are found in this document.
The use of these forms also involves electronic submission of completed applications through Grants.gov.
NIH and other PHS agencies continues to transition all activity codes to the new application forms andGrants.gov submission. NIH will continue to use Requests for Applications (RFAs) and Program
Announcements (PAs) as categories of FOAs. See Section 2.4.2 for definitions.
Applicants must carefully review FOAs for guidance on when to use the SF424 (R&R) forms,
instructions, and electronic submission for a specific activity code (i.e., P01, P20, P50, etc.). This process
will apply to all types of submissions for the announced activity code—new, resubmission, renewal, andrevision grant applications. Each FOA will include a link to the most current version of these instructions.
Applicants are encouraged to check the website frequently for the most current version.
For purposes of this document, any references to “NIH” may also mean “NIH and other PHS agencies”
such as the Agency for Healthcare Research and Quality (AHRQ), the Centers for Disease Control andPrevention (CDC), and the Food and Drug Administration (FDA).

1.1 Application Guide Format
This application guide is organized into three distinct parts:
Part I: Instructions for Preparing and Submitting the Application. Part I includes specificinstructions for completing the application forms as well as information on electronically submitting
applications through Grants.gov.

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The following Parts are incorporated into this application guide by reference. They are in a separate
document titled, “Supplemental Instructions.”
Part II: Supplemental Instructions for Preparing the Human Subjects Section of the Research
Plan. Part II is to be used if your proposed research will involve human subjects. These instructions
assist in determining whether human subjects are involved and include scenarios and detailed
instructions for completing the PHS 398 Research Plan form.
Part III: Policies, Assurance, Definitions, and Other Information. Part III includes information
on policies, assurances, definitions, and other information relating to submission of applications to
the PHS. Applicants should refer to this document as well as the instructional materials, Grants
Information (GrantsInfo), and the relevant Grants Policy Statement for additional sources of
information. The NIH Grants Policy Statement applies to all NIH awardees; other PHS agencies use
the HHS Grants Policy Statement.

1.2 NIH Extramural Research and Research Training
Programs
The NIH Office of Extramural Research Grants homepage (http://grants.nih.gov/grants/oer.htm) provides
an array of helpful information. Applicants are encouraged to bookmark this site and visit it often.
The Division of Communications and Outreach (DCO) is the central source for general information about
NIH extramural research and research training programs, funding activity codes, the peer review system,
and application procedures. Grants Information (GrantsInfo) is a communication service within the DCO.
Information about the NIH extramural research and research training programs, funding opportunities,
and the grant application process, can be obtained by e-mailing your request to: GrantsInfo@nih.gov orby calling (301) 435-0714.

1.3 Research Grant Activity Codes and Program Guidelines
A partial list of research grant activity codes and programs are provided below. As noted in thedescriptions in Supplemental Instructions Part III: Policies, Assurances, Definitions, and Other
Information, not all awarding components use all activity codes or programs. For a complete listing of
program guidelines, visit the OER Grants website
http://grants.nih.gov/grants/funding/funding_program.htm.
Research Grants•

Basic Research Grant (R01)•

Small Research Grant (R03)•

Academic Research Enhancement Award (AREA) (R15)•

Exploratory/Developmental Grant (R21, R33, R21/R33)•

Small Business Innovation Research Grant (SBIR) (R43/R44)•

Small Business Technology Transfer Grant (STTR) (R41/R42)•

Program Project Grant (P01)•

Research Center Grant (P50)•

Scientific Meeting Support (R13, U13)

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Research Project Cooperative Agreement (U01)•

Research Grants to Foreign Institutions and International Organizations

Training, Fellowships and Career Development Programs•

NIH Institutional Ruth L. Kirschstein National Research Service Award (T32)•

Individual Ruth L. Kirschstein National Research Service Award Fellowships (NRSA) (F30, F31,
F32, F33, F34, etc.)•

Research Career Development Award (K Award)

Applications Available from Other Offices•

Health Services Project Application (5161-1)

1.4 Interactions with PHS Staff
The PHS agencies encourage applicants to communicate with staff throughout the entire application,
review and award process. Website addresses and staff phone numbers of relevant NIH awarding
components and other PHS agencies are listed in the table below.
Table 1.4-1. PHS Agency Contact Table
PHS AGENCY(LINK TO WEBSITE)
National Institutes of Health(NIH)

AWARDING COMPONENT(LINK TO WEBSITE)TELEPHONE
NUMBER

Eunice Kennedy Shriver National Institute of Child Health andHuman Development

301-496-0104

NIH

Fogarty International Center

301-496-1653

NIH

National Cancer Institute301-496-3428

NIH

National Center for Complementary and Alternative Medicine

301-496-4792

NIH

National Center for Advancing Translational Sciences301-496-6023

NIH

National Eye Institute301-451-2020

NIH

National Heart, Lung, and Blood Institute301-435-0260

NIH

National Human Genome Research Institute301-496-7531

NIH

National Institute on Aging

301-496-9322

NIH

National Institute on Alcohol Abuse and Alcoholism

301-443-4375

NIH

National Institute of Allergy and Infectious Diseases

301-496-7291

NIH

National Institute of Arthritis and Musculoskeletal and Skin Diseases

301-594-2463

NIH

National Institute of Biomedical Imaging and Bioengineering

301-451-4792

NIH

National Institute on Deafness and Other Communication Disorders

301-496-1804

NIH

National Institute of Dental and Craniofacial Research301-594-4800

NIH

National Institute of Diabetes and Digestive and Kidney Diseases

301-594-8834

NIH

National Institute on Drug Abuse

301-443-2755

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PHS AGENCY(LINK TO WEBSITE)

AWARDING COMPONENT(LINK TO WEBSITE)TELEPHONE
NUMBER

NIH

National Institute of Environmental Health Sciences

919-541-7723

NIH

National Institute of General Medical Sciences301-594-4499

NIH

National Institute of Mental Health301-443-3367

NIH

National Institute on Minority Health and Health Disparities

301-402-1366

NIH

National Institute of Neurological Disorders and Stroke

301-496-9248

NIH

National Institute of Nursing Research301-594-6906

NIH

National Library of Medicine

301-496-4621

NIH

Center For Scientific Review

301-435-0715

Agency for Healthcare Research and Quality

301-427-1447

Coordinating Center for Health Information and Services

404-498-1186

CDC

Office of Infectious Disease404-639-3770

CDC

National Center for Environmental Health770-488-4668

CDC

National Center for Injury Prevention and Control

800-232-4636

CDC

National Center for Chronic Disease Prevention and Health
Promotion

770-488-8390

CDC

National Institute for Occupational Safety and Health404-498-2530

CDC

Procurement and Grants Office770-488-2700

Food and Drug
Administration

Food and Drug Administration

301-827-7185

Indian Health Service

301-443-0578

Agency for Toxic
Substances and Disease
Registry

Agency for Toxic Substances and Disease Registry404-842-6630

Office of Public Health andScience

Office of Population Affairs

301-594-4004

Office of Public Health andScience

Office of Family Planning

301-594-4008

Agency for Healthcare
Research and Quality
Centers for Disease Control
and Prevention (CDC)

Indian Health Service

Before Submission
You may wish to contact NIH staff with a variety of questions before submitting an application.
Contact GrantsInfo and/or the Division of Receipt and Referral, Center for Scientific Review (CSR),NIH:•

To identify Institutes/Centers (ICs) at NIH or other non-NIH agencies and/or a Scientific Review
Group (SRG) that might be appropriate for your application. Note requests for assignment to an
Institute/Center and/or a SRG may be made in a cover letter at the time of application submission.

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To learn about grant programs.

•

To receive advice on preparing and submitting an application (e.g., format, structure).

Contact program staff in the relevant awarding component:•

To determine whether your proposed application topic would fit into the NIH IC’s or other nonNIH agency’s programmatic area.

•

To learn about programmatic areas of interest to the IC or other non-NIH agencies.

•

To find out about requesting an assignment to an IC.

•

To discuss whether you should respond to an RFA.

Contact Scientific Review Officers in the CSR to discuss requesting assignment to a CSR SRG.
After Submission
If the initial assignment to an IC or SRG seems inappropriate, the Program Director/Principal Investigator(PD/PI) may request reassignment. Such requests should be made in writing to:Division of Receipt and Referral
Center for Scientific Review
National Institutes of Health6701 Rockledge Drive, Suite 2030, MSC 7720
Bethesda, MD 20892-7720
Fax requests (301-480-1987) are also acceptable.
Although these requests will be carefully considered, the final determination will be made by the PHS
agency.
Applicants must never contact reviewers regarding their applications because discussion of the scientificcontent of an application or an attempt to influence review outcomes will create serious breaches ofconfidentiality in the review process. Reviewers are required to notify the Scientific Review Officer ifthey are contacted by an applicant. Communication by the applicant to a reviewer may delay the review
or result in the return of the application without review.
Communications from the Division of Receipt and Referral (DRR) are accessible to applicants andapplicant organizations in the eRA Commons in a new “Correspondence” section of the Commonsdetailed status screen for the application. Applicants will be notified by email to check their Commonsaccount. DRR will notify an applicant when: 1) additional information is required before her/his
application can be assigned to a scientific review group (SRG) and NIH Institute or Center (IC) for
funding consideration; 2) an applicant’s request for an IC assignment cannot be honored; or 3) it has been
determined that the application does not comply with NIH policy. For additional information, see NIH
Guide Notice NOT-OD-12-108.
After Assignment
Contact your Scientific Review Officer to discuss the review assignment, to request permission to sendadditional/corrective materials, and/or to discuss any review concerns (e.g., expertise needed on your
SRG, conflicts, reviewers that may have bias).
After Peer Review
Feedback to applicants is very important. Once the PD/PI reviews the Summary Statement in the eRA
Commons, the appropriate awarding component program official noted in the Summary Statement may
be contacted:

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To discuss the review outcome of the application and obtain guidance.

•

To get feedback and answers to any questions about the Summary Statement.

•

To find out the meaning of a numerical designation pertaining to human subjects or vertebrate
animals in the Summary Statement.

•

To find out the funding status of an application.

A paper copy of the Peer Review Outcome Letter and Summary Statement will not be mailed to the PI
and may only be accessed through the eRA Commons.

1.5 Grants Policy Statements•

The NIH Grants Policy Statement serves as a term and condition of award and is a compilation of
the salient features of policies and various policy issues regarding the administration of NIH
awards.

•The HHS Grants Policy Statement serves as a term and condition of award and is a compilationof the salient features of policies and various policy issues regarding the administration of grantawards from other PHS agencies, excluding NIH awards.

1.6 References
Applicants New to NIH: Getting Started
http://grants.nih.gov/grants/useful_links.htm
Award Information and Data
http://report.nih.gov/index.aspx
NIH Research Portfolio Online Reporting Tool (RePORT)
Contact Information for an NIH Staff Person
http://ned.nih.gov
NIH locator: (301) 496-4000
Applying Electronically
For additional information on the electronic submission process, including self-help resources,
training material and answers to frequently asked questions, see:
http://grants.nih.gov/grants/ElectronicReceipt/index.htm
eRA Commons
https://commons.era.nih.gov/commons/index.jsp
Institutions and PD/PIs are required to register with the eRA Commons. Registered PD/PIs cancheck assignment/contact information, review outcome, and other important information. For moredetails on Commons registration, see Section 2.2.2.
E-mail: commons@od.nih.gov.
Telephone: 1-866-504-9552 (toll-free) or 301-402-7469; 301-451-5939 (TTY). Business hours are
M-F 7am-8pm Eastern Time.

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Grant Writing Tips and Sample Applications
http://grants.nih.gov/grants/grant_tips.htm
Grants Information
http://grants.nih.gov/grants/giwelcome.htm
E-mail: GrantsInfo@nih.gov
Telephone: (301) 435-0714; (301) 451-5936 (TTY)
Grants.gov User Guide
The Grants.gov User Guide is a comprehensive reference to information about Grants.gov.
Applicants can download the User Guide at the following address:
http://www.grants.gov/assets/ApplicantUserGuide.pdf.
NIH Office of Extramural Research Human Subjects Website
http://grants.nih.gov/grants/policy/hs/index.htm
This site provides, in one place, DHHS and NIH requirements and resources for the extramuralcommunity involved in human subjects research.
Office for Human Research Protections (Department of Health and Human Services)
http://www.hhs.gov/ohrp
Information about human subject protections, Institutional Review Boards, and Federal Wide
Assurances
Telephone: 1-866-447-4777 or (301) 496-7005
Office of Laboratory Animal Welfare (OLAW)
http://olaw.nih.gov
Information about animal welfare policy requirements, Institutional Animal Care and Use
Committees (IACUC), and Animal Welfare Assurances
Telephone: (301) 496-7163
Receipt/Referral of an Application
http://www.csr.nih.gov/EVENTS/AssignmentProcess.htm
Division of Receipt and Referral
Center for Scientific Review
Telephone: (301) 435-0715
Fax: (301) 480-1987
Specific Application: Before Review
Telephone or e-mail the Scientific Review Officer identified for the application in the eRA
Commons.
Specific Application: Post Review
Telephone or e-mail the NIH Program Official named in the Summary Statement for the application.

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1.7 Authorization
The PHS requests the information described in these instructions pursuant to its statutory authorities forawarding grants, contained in Sections 301(a) and 487 of the PHS Act, as amended (42 U.S.C. 241a and42 U.S.C. 288). Therefore, such information must be submitted if an application is to receive due
consideration for an award. Lack of sufficient information may hinder the ability of the PHS to review anapplication and to monitor the grantee’s performance.

1.7.1 Collection of Personal Demographic Data
Federal agencies have a continuing commitment to monitor the operation of its review and award
processes to detect, and deal appropriately with, any instances of real or apparent inequities. In addition,section 403 of the 2007 NIH Reform Act requires NIH to report to Congress specifically on postdoctoral
individuals supported on research grants, and section 489 of the PHS Act requires NIH to perform acontinuing assessment of research personnel needs. Personal demographic data on PD/PIs and those witha postdoctoral role is vital to comply with these requirements.
NIH collects personal data through the eRA Commons Personal Profile. The data is provided one-time by
the individual through a secure, electronic system, is confidential, and is maintained under the Privacy
Act record system 09-25-0036, “Grants: IMPAC (Grant/Contract Information).” When completing thedata entry in the Commons Personal Profile, the individual is responsible for providing true, accurate, andcomplete data. All analyses conducted on date of birth, citizenship, gender, race, ethnicity, disability,
and/or disadvantaged background data will report aggregate statistical findings only and will not identify
individuals. Declining to provide information does not affect consideration of an application; however,for some programs (e.g., Ruth L. Kirschstein National Research Service Awards and Research Career
Development Awards) citizenship data is required to determine eligibility.
The PHS also requests the last four digits of the Social Security Number (SSN) for accurate identificationof individuals and for management of PHS grant programs. Please be aware that no individual will bedenied any right, benefit, or privilege provided by law because of refusal to disclose this portion of the
SSN. The PHS requests the last four digits of the SSN under Section 301(a) and 487 of the PHS act asamended (42 U.S.C. 241a and U.S.C. 288).

1.8 Paperwork Burden
The PHS estimates that it will take approximately 22 hours to complete this application for a regularresearch project grant. This estimate excludes time for development of the scientific plan. Other items
such as human subjects are cleared and accounted for separately and therefore are not part of the time
estimate. An agency may not conduct or sponsor the collection of information unless it displays acurrently valid OMB control number. Nor is a person required to respond to requests for the collection of
information without this control number. Send comments regarding this burden estimate or any otheraspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project
Clearance Office, 6705 Rockledge Drive MSC 7974, Bethesda, MD 20892-7974, ATT: PRA (09250001). Do not send applications or any materials related to training or career award applications to thisaddress.

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2.

Process for Application Submission via
Grants.gov

Application submission through Grants.gov involves several steps. Some of the steps need only be done
one time. Others are ongoing steps that will be necessary for each application submission. Before
beginning the application process, you are encouraged to review Grants.gov and all the resources
available there.

2.1 Overview
The following steps must be taken in order to submit a grant application through Grants.gov. Please be
sure to complete all steps to ensure that NIH receives the application in a timely manner.
1. Register your organization at Grants.gov. (This is a one-time only registration process for all
Federal agencies. However, an annual renewal of information provided to the System for AwardManagement (SAM) is necessary to retain active Grants.gov credentials. If your organization has
already completed this step for any Federal agency submission, skip to step #2. If yourorganization has not completed this step, see Section 2.2 for more details.)
2. Register your organization and Program Director/Principal Investigator (PD/PI) in the eRA
Commons. (This is a one-time only registration process. If your organization has alreadycompleted this step, skip to step #3. If your organization has not completed this step, see Section
2.2 for more details.)
3. Find a Funding Opportunity Announcement (FOA) of interest using the NIH Guide for Grants
and Contracts or Grants.gov’s “Find Grants” feature. (See Section 2.4 for more details.)
4. Download the associated Application Package from Grants.gov. (Adobe Reader required for
download. See Section 2.3 for more details.)
5. Complete the appropriate application forms, including all text and PDF attachments. Upload all
attachments into the appropriate application form (See Section 2.6 for more details on therequirements for text (PDF) attachments).
6. Review the completed application through your own organizational review process.
7. Coordinate with an Authorized Organization Representative (AOR) at the applicant organization
to submit the application by the date and time specified in the FOA. (Keep a copy locally at the
Applicant Organization/Institution.)
8. Receive the Grants.gov tracking number.
9. After successfully passing Grants.gov and agency validation, receive the agency tracking
number (accession number). Note: Any errors encountered at Grants.gov or eRA Commonsmust be corrected in order to successfully complete your submission.
10. PD/PI and Signing Official (SO) must view the application in eRA Commons to ensure theassembled application correctly reflects their submission. (See Section 2.11 for detailed
information.)
The following sections explain each step in more detail.

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2.2 Registration Processes
2.2.1 Grants.gov Registration
Grants.gov requires a one-time registration by the applicant organization in order to submit applications.
Registration is not needed to download an application package or to prepare an application for
submission. PD/PIs do not have to individually register in Grants.gov unless they also serve as the
Authorized Organization Representative (AOR) for their institution/organization. If an applicant
organization has already completed Grants.gov registration for another Federal agency, they can skip thissection and focus on the eRA Commons registration steps noted below. For those applicant organizations
still needing to register with Grants.gov, registration information can be found at the Grants.gov Get
Registered tab (http://grants.gov/applicants/get_registered.jsp). While Grants.gov registration is a onetime only registration process, it does involve several steps and will take some time. Applicant
organizations needing to complete this process are encouraged to start early allowing at least six (6)weeks to complete all the steps before actually submitting an application through Grants.gov.
All registrations require that applicants be issued a Dun and Bradstreet Universal Numbering System(DUNS) number. After obtaining a DUNS number, applicants can begin both System for AwardManagement (SAM) (formerly CCR) and eRA Commons registrations. The same DUNS number must be
used for all registrations and on the grant application itself.
Note that all applicant and grantee organizations must complete and maintain an active entity registrationin SAM which requires renewal at least annually. This requires that you review and update theinformation at least annually after the initial registration, and more frequently if required by changes inyour information or another award term. The renewal process may require as much time as the initial
registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE)
Code for domestic organizations which have not already been assigned a CAGE Code. Foreignorganizations must obtain a NATO Commercial and Government Entity (NCAGE) code (in lieu of a
CAGE code) in order to register in SAM. Use the SAM.gov "Manage Entity" function to manage yourentity registrations. See the Grants Registrations User Guide at http://www.sam.gov for additional
information.
For additional information regarding maintaining an active SAM registration, please see NIH Guide
Notice NOT-OD-11-004.
The AOR is an individual authorized to act for the applicant organization and to assume the obligations
imposed by the Federal laws, requirements, and conditions for a grant or grant application, including theapplicable Federal regulations. This individual has the authority to sign grant applications and required
certifications and/or assurances that are necessary to fulfill the requirements of the application process.
Once this individual is registered, the organization can then apply for any government funding
opportunity listed in Grants.gov, including NIH and other PHS agencies grants.
Questions regarding Grants.gov registration should be directed to the Grants.gov Contact Center at
telephone: 1-800-518-4726 or by e-mail at support@grants.gov. The Contact Center is available 24 hours
a day, 7 days a week.

2.2.2 eRA Commons Registration
The applicant organization, all PD/PIs, and all individuals with a postdoctoral role (see definition of
postdoctoral scholar in Supplemental Instructions Part III.3) and one month or more of measurable effort
must also complete a one-time registration in the eRA Commons. Individuals with a postdoctoral role do
not need an eRA Commons ID for application submission. However, individuals with a postdoctoral rolemust have an eRA Commons ID for reporting on awarded grants. Access to the Commons is vital for all

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steps in the process after application submission. An organization and PD/PIs must be registered in the
Commons before they can take advantage of electronic submission and retrieval of grant information,such as reviewing grant applications, institute/center assignments, review outcomes, and Summary
Statements. Applicants must have an active DUNS number in order to complete the eRA Commonsregistration. Organizations can register with the eRA Commons as they are working through their SAM
or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official(SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit anapplication. Institutional/organizational officials are responsible for registering PD/PIs and individuals
with a postdoctoral role in the eRA Commons. PD/PIs and individuals with a postdoctoral role should
work with their AOR (also known as the Signing Official in the eRA Commons) to determine their
institutional/organizational process for registration.
IMPORTANT: The eRA Commons registration process should be started at least six (6) weeks prior to
the submittal date of a Grants.gov submission. Failure to register in the Commons and to include a valid
PD/PI Commons ID in the credential field of the Senior/Key Person Profile Form will prevent thesuccessful submission of an electronic application to NIH. Commons user name IDs for those with apostdoctoral role are not required at the time of application submission, but are required as part of the
Non-Competing Continuation Progress Report (RPRR or PHS 2590).
2.2.2.1

Commons Registration for the Organization

Organizations may verify their current registration status by accessing the “List of Grantee Organizations
Registered in eRA Commons” (http://era.nih.gov/commons/quick_queries/index.cfm#commons).
To register an Organization in the eRA Commons:
1. Complete the online Institution Registration Form at:https://public.era.nih.gov/commons/public/registration/registrationInstructions.jsp
2. Print and fax the registration pagea. The Signing Official (SO) must sign, date and fax the registration to the number listedon the form
3. Signing Official must verify email address
a. Once the registration is submitted electronically, email verification is sent and the SO
must click the link to verify emailb. The above steps must be completed before NIH can process the registrationc. The SO will receive an “Approval” email from NIH
d. The “Approval” email contains a link to information that you must verify as correct
before the confirmation process is completed
4. Account Administrator (AA) receives user names and temporary passwords
a. After the completion of the confirmation, the SO and AA will receive two emails that
contain the user names and temporary password for the SO and AA accounts createdduring the registration process
5. Log into Commonsa. The SO and AA log into Commons and administer additional accounts as needed
6. Affiliate your PIs
a. Your Principal Investigators must work with your organization to be registered in
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must affiliate it with your organization. Verify that you’ve selected the correct PI
account!
For more information, see http://era.nih.gov/commons/faq_commons.cfm#II2.
This registration is independent of Grants.gov and may be done at any time.
Organizational data elements, such as Institutional Profile Number (IPF), Entity Identification Number(e.g., 5555555555A5) and DUNS Number must be accurately identified. Note the DUNS number must
be included in the Institutional Profile for applications to be accepted. In addition, the DUNS
number in the Institutional Profile must match that entered in the SF424 (R&R) Cover Form in
Section 5, Applicant Information.
Prior to submission, the AOR/SO should verify that their organization’s eRA Commons profile contains
the valid DUNS number that will be used for the submission process. The SO has the ability to edit thisfield in the organization profile in Commons.
To confirm that your organization has a DUNS number or to find out if the DUNS number you havematches the one in Commons, access the List of Grantee Organizations Registered in eRA Commons(http://era.nih.gov/commons/quick_queries/index.cfm#commons). This listing of grantee organizations
registered in Commons and their DUNS numbers can be accessed without logging into Commons.
2.2.2.2

Commons Registration for the Program Directors/Principal Investigators(PD/PIs) and Individuals with a Postdoctoral RoleOnce the organization is registered in the Commons, individuals can then be registered. All PD(s)/PI(s)must have an eRA Commons account and the PI Role and should work with their organizational officials
to either create a new account or to affiliate an existing account with the applicant organization’s eRA
Commons account. If the PD/PI is also the organizational signing official, they must have two distinct
eRA Commons accounts, one for each role. This registration must be done by an organizational
official (or delegate) who is already registered in the Commons. If submitting an application reflecting
Multiple PD/PIs, the individual designated as the contact PI must be affiliated with the applicant
organization. To register PD/PIs in the Commons, refer to the eRA Commons System Users Guide(http://era.nih.gov/commons/user_guide.cfm). For applications reflecting Multiple PD/PIs, all suchindividuals must be assigned the PI role, even those at organizations other than the applicant organization.
Once a PD/PI has received e-mail confirming his/her registration within the Commons, the PD/PI mustverify that all Personal Information located within the Personal Profile tab in the eRA Commons Systemis accurate. Please have the PD/PI review and update, as needed, data elements such as first name, middle
initial, last name, prefix and/or suffix to PD/PI name (including all embedded punctuation), e-mail,phone, fax, street address, city, state, country, zip and degrees earned. These data must contain the mostrecent information in order for the application to be processed accurately.
Both PD/PI and SO need separate accounts in Commons since each role enables different features withineRA Commons. For example, an SO can Reject a submitted application to prevent it from being sent on
to agency staff. A PI has access to review outcome information (scores and summary statement). If you
are the SO for your organization as well as a PD/PI of the grant, you will need two separate accounts withdifferent user names – one with SO authority and one with PI authority. When an organization isregistered, an SO account is created. Log on to the account with the SO authority role and create anotheraccount with PI authority.
Individuals with a postdoctoral role and one month or more of effort must also be registered in the eRA
Commons and should verify that all Personal Information located within the Personal Profile tab in theeRA Commons system is accurate. The Commons user name ID for those with a postdoctoral role is not
required at the time of application submission, but will be required as part of the Non-Competing
Continuation Progress Report (RPRR or PHS 2590).

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For additional information on how to prepare for electronic submission, see:
http://grants.nih.gov/grants/ElectronicReceipt/preparing.htm.

2.3 Software Requirements
2.3.1 Adobe Reader
In order to access, complete and submit applications using Grants.gov’s downloadable forms, applicantsneed to download and install the Adobe Reader, version 8.1.1 or later. For minimum system requirements
and download instructions, please see the Grants.gov User Guide or visit
http://grants.gov/help/download_software.jsp.

2.3.2 Creating PDFs for Text Attachments
NIH and other PHS agencies require all text attachments to the SF424 (R&R) application forms to besubmitted as PDF files.
Applicants should prepare text attachments using any word processing program (following the format
requirements in Section 2.6) and then convert those files to PDF before attaching the files to theappropriate form in the application package. (The PDF format is used to preserve document formatting.)
Save all files with descriptive file names of 50 characters or less and be sure to only use standard
characters in file names: A through Z, a through z, 0 through 9, underscore (_), hyphen (-), space ( ), andperiod (.). Do not use any other special characters (e.g., “&”, “*”, “%”, “/”, or “#”) in the file name.
Some type of PDF-creation software is necessary to create the PDF. (The free Adobe Reader will not
create a PDF.) To assist applicants searching for free PDF-creation software, Grants.gov has published alist of available tools and software, see Grants.gov’s Download Software page at
http://www.grants.gov/help/download_software.jsp.
Note that all PDF attachments must be submitted as individual files. Although some software packages
allow bundling of multiple PDFs into a single file, eRA systems cannot support “Bundling” or “Portfolio”
features at this time. Use of these features may result in delays in the review of an application or an
application not being reviewed.
It is recommended that, as much as possible, applicants avoid scanning text documents to produce therequired PDFs. Instead, NIH recommends producing the documents electronically using text or wordprocessing software and then converting documents to PDF. Scanning paper documents, without theproper Optical Character Recognition (OCR) process, will hamper automated processing of yourapplication for NIH analysis and reporting.
DISCLAIMER: References to software packages or Internet services neither constitute nor should be
inferred to be an endorsement or recommendation of any product, service, or enterprise by the NIH orother PHS agencies, any other agency of the United States Government, or any employee of the UnitedStates Government. No warranties are stated or implied.

2.3.3 Special Instructions for Macintosh Users
With the conversion to Adobe Reader application submissions there are no longer special instructions for
Macintosh users.

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2.4. Funding Opportunities
Grants for health-related research and research training projects or activities make up the largest categoryof funding provided by the NIH Institutes/Centers (ICs) and other non-NIH agencies. Most applications
for support are unsolicited and originate with individual investigators who develop proposed plans forresearch or research training within an area that is relevant to the NIH. Research project grants areawarded to organizations/institutions on behalf of PD/PIs to facilitate the pursuit of a scientific objective
when the idea for the research is initiated by the investigator. If the funding agency anticipates substantial
program involvement during the conduct of the research, a cooperative agreement will be awarded rather
than a grant. The NIH typically awards grants and cooperative agreements for terms ranging from one to
five years. Organizational/institutional sponsorship assures that the awardee organization will provide thefacilities and the financial stability necessary to conduct the research, and be accountable for the funds.
For a list and brief description of grant activity codes, see Supplemental Instructions Part III: Policies,
Assurances, Definitions, and Other Information.

2.4.1 NIH Guide for Grants and Contracts
The NIH Guide for Grants and Contracts (http://grants.nih.gov/grants/guide), a weekly electronic
publication, contains announcements about funding opportunities, such as Requests for Applications(RFAs) and Program Announcements (PAs), including Parent Announcements, from NIH and other PHS
agencies. The NIH Guide also contains vital information about policies and procedures. To subscribe to
the NIH Guide, visit http://grants.nih.gov/grants/guide/listserv.htm.

2.4.2 Funding Opportunity Announcements
To hasten the development of a program or to stimulate submission of applications in an area of highpriority or special concern, an awarding component will encourage applications through the issuance of a
PA to describe new, continuing, or expanded program interests, or issuance of an RFA inviting
applications in a well-defined scientific area to accomplish a scientific purpose.
Definitions are as follows:
Parent Announcements: Electronic grant applications must be submitted in response to a Funding
Opportunity Announcement (FOA). For applicants who wish to submit what were formerly termed“investigator-initiated” or “unsolicited” applications, NIH and other PHS agencies have developed Parent
Announcements. Responding to such an omnibus or umbrella Parent FOA ensures that the correct
application package is used and enables NIH to receive the application from Grants.gov. Additional
information about, as well as links to published Parent Announcements, can be found at:
http://grants.nih.gov/grants/guide/parent_announcements.htm.
Program Announcement (PA): A formal statement about a new or ongoing extramural activity or
program. It may serve as a reminder of continuing interest in a research area, describe modification in an
activity or program, and/or invite applications for grant support. Most applications in response to PAs
may be submitted to a standing submission date and are reviewed with all other applications received atthat time. NIH may also make funds available through PARs (Program Announcements with special
receipt, referral, and/or review considerations) and PASs (Program Announcements with set-aside funds).
Request for Applications (RFA): A formal statement that solicits grant or cooperative agreement
applications in a well-defined scientific area to accomplish specific program objectives. An RFA indicatesthe estimated amount of funds set aside for the competition, the estimated number of awards to be made,and the application submission date(s). Applications submitted in response to an RFA are usuallyreviewed by a Scientific Review Group (SRG) specially convened by the awarding component that issued
the RFA.

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PAs (including Parent Announcements) and RFAs are published in the NIH Guide for Grants andContracts (http://grants.nih.gov/grants/guide) and on Grants.gov under Find Grant Opportunities(http://www.grants.gov/applicants/find_grant_opportunities.jsp). Read the announcement carefully forspecial instructions. The instructions in the announcement may differ from these general instructions, andthe instructions in the announcement always supersede these general instructions. Each announcement
published in the NIH Guide for Grants and Contracts, Grants.gov Find, or other public document
contains contact information under Inquiries in addition to information specific to the announcement.
While individual announcements will continue to carry an announcement number reference to “PA” or“RFA”, all announcements are “Funding Opportunity Announcements (FOAs).” This general term will be
used to reference any type of funding announcement. NIH will continue to use the PA and RFA
references in the actual announcement number to distinguish between the various types ofannouncements.
In reading any FOA in the NIH Guide for Grants and Contracts:•

A “Posted Date” refers to the date the FOA is posted on Grants.gov. An applicant can download
the application package on that date and begin filling it out. However, the applicant has to wait
until the FOA’s “open date” to submit the application.

•

An application can be submitted anytime between the “open date” and the “application duedate(s)” noted for AIDS and non-AIDS applications. (Standard dates may apply; check
http://grants.nih.gov/grants/funding/submissionschedule.htm for details.)•

When you download an application package from Grants.gov, the “expiration date” is prepopulated. Do not go strictly by this date since it may not apply to your particular situation; forinstance, it may reflect the submission date for AIDS applications and you may be submitting a
non-AIDS application that is due earlier. In this case, the pre-populated date has no bearing on
your application and you should not be concerned by it.

All applications submitted to the NIH must be submitted in response to a FOA published in the NIH
Guide for Grants and Contracts.

2.4.3 Finding a Funding Opportunity Announcement (FOA) for
Grants.gov Submission
Implementation of the SF424 (R&R) application and electronic submission through Grants.gov will beannounced through specific FOAs posted in the NIH Guide for Grants and Contracts and on Grants.gov
under “Find Grants” (a.k.a. “Find”) and “Apply for Grants” (a.k.a. “Apply”). From the “For Applicants”
section of the Grants.gov home page, select “Apply for Grants” and follow the steps provided. FOAs
posted in Grants.gov Apply reflect those the agency is prepared to receive through electronic Grants.gov
submission. Applicants are encouraged to read each FOA carefully for specific guidance on the use of
Grants.gov submission.
There are several ways a prospective applicant can find a FOA on Grants.gov.
Using the NIH Guide for Grants and Contracts
FOAs in the NIH Guide for Grants and Contracts that reference electronic submission via Grants.gov
include a link from the FOA directly to the Grants.gov site where you can download the specificapplication package. The Apply for Grants Electronically button is found in the NIH Guide FOA
directly above the Table of Contents. This link is only provided in those announcements involving
electronic submission through Grants.gov.

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Using “Find Grants” (Find) Feature
Grants.gov Find provides general search capabilities. From the “Search Grants” page, you will findvarious options for: providing search criteria (e.g., keyword, Funding Opportunity Number, status, etc.)
and identifying FOAs of interest.
Once you find an opportunity for which you wish to apply, you may initiate the application download
process by selecting the “Application Package” tab.
Using “Apply for Grants” (Apply) Feature
If you know the specific funding opportunity number, a more direct route is to use the “Apply for Grants”
feature. From the Grants.gov home page, select “Apply for Grants” and follow the steps provided. “Step1” allows you to download an application package by inserting a specific Funding Opportunity Number(FOA). If you do not know the specific Funding Opportunity Number there is a link that will take you
back to the Search Grants page.

A Funding Opportunity Announcement (FOA) Number is referenced in every announcement. Enter thisnumber in the Funding Opportunity Number field and click Download Package. This takes you to a
“Selected Grant Applications for Download” screen.

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Click the corresponding download link to access the actual application form pages and instruction
material. If more than one application package is listed, use the Competition ID and Competition Title todetermine the appropriate package to download. The following screens appear:

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To access the instructions, click Download Application Instructions. For NIH opportunities and other
PHS agencies using this Application Guide, this action will download a document containing a link to the
NIH website where the most current set of application instructions is available(http://grants.nih.gov/grants/funding/424/index.htm). Applicants are encouraged to check this site
regularly for the most current version.
To access the form pages, click Download Application Package. Section 2.5 provides specificinformation regarding the forms for an Application Package. Section 3 provides additional instructions forproperly using a package.
On the Download Opportunity Instructions and Applications screen you will be given an opportunity toprovide an e-mail address if you would like to be notified of any changes to this particular opportunity.
Applicants to NIH and other PHS agencies are strongly encouraged to complete this information. The
agency can then use it to provide additional information to prospective applicants.
Note: The forms may or may not show a CFDA number and the CFDA field is not editable. Do not be
concerned. The CFDA number is not used for assignment of the application. Be assured the correct
CFDA number will be assigned to the record once the appropriate IC assignment has been made.

2.5 Forms for an Application to NIH or Other PHS Agencies
The SF424 (R&R) form set comprises a number of forms, each listed in the table below as a separate“document.” In addition to these forms, NIH and other PHS agencies applicants will also complete
supplemental forms listed as “PHS 398” forms in the table below.

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Table 2.5-1. Table 2.5-1. Forms for an NIH or Other PHS Agencies Application
DOCUMENTREQUIREDOPTIONAL

INSTRUCTIONS

SF424 (R&R) Coverx

Section 4.2

SF424 (R&R) Project/Performance Site Locations

x

Section 4.3

SF424 (R&R) Other Project Informationx

Section 4.4

SF424 (R&R) Senior / Key Person Profile(s)xSection 4.5

SF424 (R&R) Budget*

Section 4.7(Use when required or allowed by the FOA)x

SF424 (R&R) Subaward Budget Attachment Form

Section 4.8(Use when required or allowed by the FOA)

PHS 398 Cover Page Supplementx

Section 5.3

PHS 398 Modular Budget*

Section 5.4

xSection 5.5(Use when required or allowed by the FOA)

PHS 398 Research Plan
(Not required for Career Development Award (K)orInstitutional Training Award (T) applications)

Planned Enrollment ReportxSection 5.8

PHS 398 Cumulative Inclusion Enrollment ReportxSection 5.8

PHS 398 Career Development Award Supplemental
Formx

Section 7.5

xSection 8.7*

Section 8.5(Required only for Career Development Award (K)applications)

PHS 398 Research Training Program Plan
(Required only for Institutional Training Award (T)applications)

PHS 398 Training Budget(Use when required or allowed by the FOA)

PHS 398 Training Subaward Budget Attachment*

Section 8.6(Use when required or allowed by the FOA)

* The application forms package associated with most NIH research grant funding opportunities includes two
optional budget forms: (1) SF424 (R&R) Budget and (2) PHS 398 Modular Budget. NIH application submissions
must include either the SF424 (R&R) Budget Form or the PHS 398 Modular Budget Form, but never both. (Note
AHRQ does not accept modular budgets.) Unless otherwise stated in a funding announcement, an applicationmust always be submitted with a budget form. For those programs where either form is a possibility, the budget
forms will be considered “optional” by the Grants.gov package. Nonetheless, it is still required that you select andsubmit one of these budget forms for an application to be accepted by the NIH.
To determine which budget form to use for NIH applications, consult the modular budget guidelines found in
Section 5.4. Additional guidance may also be provided in the specific funding opportunity announcement.
Some funding opportunities will explicitly state the use of only one of the budget forms. In this case, the application
package will only include the accepted budget form which will appear in the list of “mandatory” forms (not in theoptional list).

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For a small number of programs (e.g., S10, DP1, DP2, DP3, X01, X02), neither budget form is included and theonly budget information required is the Estimated Project Funding section of the SF424 (R&R) cover.

All required and optional forms for electronic submission listed above are available through Grants.gov and should
be downloaded from the FOA being applied to. Do not use any forms or format pages from other sources; these
may include extraneous headers/footers or other information that could interfere with the electronic application
process.

2.6 Format Specifications for Text (PDF) Attachments
Designed to maximize system-enforced validations, multiple separate attachments are required for acomplete application. When the application is received by the agency, all submitted forms and all separate
attachments are combined into a single document that is used by peer reviewers and agency staff.
NIH and other PHS agencies require all text attachments to the Adobe application forms be submitted as
PDFs and that all text attachments conform to the agency-specific formatting requirements noted below.
Failure to follow these requirements may lead to rejection of the application during agency validation ordelay in the review process. (See Section 2.3.2 for more information on creating PDFs.)
Text attachments should be generated using word processing software and then converted to PDF using
PDF generating software. Avoid scanning text attachments to convert to PDF since that causes problems
for the agency handling the application. Additional tips for creating PDF files can be found at
http://grants.nih.gov/grants/ElectronicReceipt/pdf_guidelines.htm.
When attaching a PDF document to the actual forms, please note you are attaching an actual document,
not just pointing to the location of an externally stored document. Therefore, if you revise the document
after it has been attached, you must delete the previous attachment and then reattach the revised
document to the application form. Use the View Attachment button to determine if the correct version
has been attached.
File Name
Save all files with descriptive file names of 50 characters or less and be sure to only use standard
characters in file names: A through Z, a through z, 0 through 9, underscore (_), hyphen (-), space ( ), andperiod (.). Do not use any other special characters (example: “&”, “*”, “%”, “/”, and “#”) or spacing in
the file name.
Font
Use an Arial, Helvetica, Palatino Linotype, or Georgia typeface, a black font color, and a font size of 11
points or larger. (A Symbol font may be used to insert Greek letters or special characters; the font size
requirement still applies.)
Type density, including characters and spaces, must be no more than 15 characters per inch.
Type may be no more than six lines per inch.
Paper Size and Page Margins
Use standard paper size (8 ½" x 11).
Use at least one-half inch margins (top, bottom, left, and right) for all pages. No information should
appear in the margins, including the PI’s name and page numbers.
Page Formatting
Since a number of reviewers will be reviewing applications as an electronic document and not a paper
version, applicants are strongly encouraged to use only a standard, single-column format for the text.

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Avoid using a two-column format since it can cause difficulties when reviewing the document
electronically.
Do not include any information in a header or footer of the attachments. A header will be systemgenerated that references the name of the PD/PI. Page numbers for the footer will be system-generated in
the complete application, with all pages sequentially numbered.
Figures, Graphs, Diagrams, Charts, Tables, Figure Legends, and Footnotes
You may use a smaller type size but it must be in a black font color, readily legible, and follow the font
typeface requirement. Color can be used in figures; however, all text must be in a black font color, clear
and legible.
Grantsmanship
Use English and avoid jargon.
If terms are not universally known, spell out the term the first time it is used and note the appropriate
abbreviation in parentheses. The abbreviation may be used thereafter.
Page Limits
Although many of the sections of this application are separate text (PDF) attachments, page limits
referenced in these instructions and/or funding opportunity announcement must still be followed. Agency
validations will include many checks for page limits. Some accommodation will be made for sections thatwhen combined must fit within a specified limitation. Note that while these computer validations will
help minimize incomplete and/or non-compliant applications, they may not address all page limit
requirements for a specific FOA and do not replace the validations conducted by NIH staff. Applications
found not to comply with the requirements may lead to rejection of the application during agency
validation or delay in the review process.
All applications for NIH and other PHS agency funding must be self-contained within specified page
limits. Unless otherwise specified in an NIH solicitation, internet website addresses (URLs) may not be
used to provide information necessary to the review because reviewers are under no obligation to view theinternet sites. Moreover, reviewers are cautioned that they should not directly access an Internet site as it
could compromise their anonymity.
Observe the page number limits given in Table 2.6-1. Only when specifically allowed in a FOA will the
PHS accept applications that exceed the page number limitations. However, specific page number limits
may apply to each subproject. For information pertaining to page number limits for such projects, contact
the awarding component to which the application may be assigned. (See Table 1.4-1. Agency Contact
Table.) The page number limitations may also be different for other specialized grant applications.
Applicants are prohibited from using the Appendix to circumvent page limitations in any section of theapplication for which a page limit applies. For additional information regarding Appendix material andpage limits, please refer to the NIH Guide Notice NOT-OD-11-080.

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Table 2.6-1. Page Limits

Please visit http://grants.nih.gov/grants/forms_page_limits.htm for a more detailed Table of Page
Limits.
SECTION OF APPLICATION
Also refer to the relevant section of the application instructions and the FOA.

Introduction to Resubmission Application

PAGE LIMITS *1 page(3 pages for R25 on PHS 398 Research Plan and 3 pages for K12, T and D Training
Grants on PHS 398 Training Program Plan)

Introduction to Revision Application

1 pageSpecific Aims

1 pageResearch Strategy (Item of Research Plan)

Research Education Program Plan

6 pagesor 12 pages
or Follow FOA instructions
25 pages

For R25 Research Education Grant Applications

Plan for Instruction in the Responsible Conduct of Research
Required for all Training Grant Activity Codes

3 pagesRequired for all Individual Career Development Grant Activity Codes
1 pageBiosketch (per person)

4 pages(2 pages for DP1 and DP2 Activity Codes)

Career Development Award (K) Application

12 pages

Upload to PHS 398 Career Development Award Supplemental Form: Combined
Candidate Information (Candidate’s Background, Career Goals and Candidate’s Plan
for Career Development/Training Activities During Award Period attachments) andResearch Strategy attachment

Institutional Research Training and Career Development Applicants,
Including Ruth L. Kirschstein NRSA Application

25 pages

Research Training Program Plan: Combined Sections 8.7.2.2 – 8.7.2.4 (Background,
Program Plan, and Recruitment and Retention Plan to Enhance Diversity)* FOA instructions always supersede these instructions.

2.7 “Resubmission” Applications
For all original new (i.e., never submitted) competing renewal applications submitted for the January 25,
2009 due date and beyond, NIH will accept only a single amendment (A1) to the original application(called a resubmission application). A lengthy hiatus after the initial submission may be marked bysignificant advances in the scientific field and the comments of the reviewers may no longer be relevant.
Therefore, a resubmission application must be submitted within 37 months after the date of receipt("receipt date") of the initial New, Renewal, or Revision application (see NOT-OD-10-140 and NOT-OD-

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12-128). After 37 months, you may submit a New application. Any second resubmission will beadministratively withdrawn and not accepted for review.
NIH has established policies for application resubmissions of certain categories. See Resubmission of
Unpaid RFA Applications and Resubmission of Applications with a Changed Grant Activity Code in
Supplemental Instructions Part III, 1.2.
There are five requirements for a Resubmission application:•

The Summary Statement must be available in the eRA Commons(http://commons.era.nih.gov/commons).

•

The PD/PI(s) must make significant changes to the application.

•

An Introduction must be included that summarizes the substantial additions, deletions, andchanges to the application. The Introduction must also include a response to the issues andcriticism raised in the Summary Statement. The Introduction is separate from the Cover Letter.
Use “ Introduction” of the PHS 398 Research Plan Form to provide this information. The page
limit for the Introduction may not exceed one page unless indicated otherwise. Please refer to therelevant section of the application instructions and the FOA.

•

The substantial scientific changes must be marked in the text of the application by bracketing,indenting, or change of typography. Do not underline or shade the changes. Deleted sections
should be described but not marked as deletions. If the changes are so extensive that essentiallyall of the text would be marked, explain this in the Introduction. The Preliminary Studies/Progress
Report section should incorporate work completed since the prior version of the application was
submitted.

•

For Mentored Career Development Award applications, new Letters of Reference must be
submitted providing an up-to-date evaluation of the applicant’s potential to become an
independent researcher, and the continued need for additional supervised research experience.

See NOT-OD-11-057 for special conditions and due dates for new investigator resubmission applications
submitted for consecutive review cycles. Note this applies only to new investigator R01s submitted forstandard receipt dates and reviewed in recurring study sections in CSR.
Acceptance of a resubmission application will not automatically withdraw the prior version. eRA keeps
all versions (e.g., 01, A1) of a grant application active and provides an internal Multiple Active
Applications (MAA) flag for each application in an active cluster. The cluster allows applicants to
identify quickly all versions of one application. If any version in a cluster is awarded, all otherapplications within the cluster will be automatically withdrawn without any additional action by
applicants or staff.
Investigators who have submitted two versions of an application and have not been successful often ask
NIH what constitutes a “new application.” It is recognized that investigators are trained in a particularfield of science and are not likely to make drastic changes in their research interests. However, a new
application following two reviews is expected to be substantially different in content and scope with moresignificant differences than are normally encountered in a Resubmission application. Simply rewording
the title and Specific Aims or incorporating minor changes in response to comments in the previous
Summary Statement does not constitute a substantial change in scope or content. Changes to the Research
Strategy should produce a significant change in direction and approach for the research project. Thus, a
new application would include substantial changes in all portions of the Specific Aims and Research
Strategy. Requests for review by a different review committee or funding consideration by a different
NIH IC are not sufficient reasons to consider an application as new.

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In the referral process, NIH staff look at all aspects of the application, not just the title and Description(abstract). Requesting review by a different review committee does not affect the implementation of thispolicy. When necessary, previous applications are analyzed for similarities to the present one. Thus,
identical applications or those with only minor changes will not be accepted for review. If identified after
assignment or review, identical applications will be withdrawn.

2.8 “Revision” Application
A Revision application (formerly called a competing supplement) may be submitted to request support fora significant expansion of a project’s scope or research protocol. Applications for revisions are notappropriate when the sole purpose is to restore awards to the full SRG-recommended level if they wereadministratively reduced by the funding agency. A revision application should not be submitted until after
the original application has been awarded and must not extend beyond the term of the current award
period.
Provide a one-page “Introduction” that describes the nature of the supplement and how it will influence
the specific aims, research design, and methods of the current grant. Use Introduction to application, of
the PHS 398 Research Plan form to provide this information. The body of the application should containsufficient information from the original grant application to allow evaluation of the proposed supplement
in relation to the goals of the original application. Note that all revision applications must be submitted by
the same PD/PI (or Contact PD/PI for multi-PI grants) as listed on the current award and applicants must
use the same budget format (i.e. R&R Budget Form or PHS 398 Modular Budget Form) as the current
award. Also, any budgetary changes for the remainder of the project period of the current grant should be
discussed in the Budget Justification.
If the revision application relates to a specific line of investigation presented in the original applicationthat was not recommended for approval by the SRG, then the applicant must respond to the criticisms in
the prior Summary Statement, and substantial revisions must be clearly evident and summarized in the“Introduction.”
Administrative Supplements
An administrative supplement provides additional funding to meet increased costs that are within thescope of an approved application, but that were unforeseen when the new or competing renewal
application was submitted. If considering administrative supplement funding, you must consult inadvance with your designated Grants Management Officer and Program Official. It is important to submit
a request before the grant expires. NIH now publishes all administrative supplement programs as FOAs,
not Guide Notices as done previously. Administrative Supplement requests may now be submitted in
response to an FOA through either the eRA Commons or Grants.gov, as described in NOT-OD-12-024,
or through the existing, paper-based process. If you submit a request in writing, you must submit to the
IC (not to the Division of Receipt and Referral, Center for Scientific Review). For additional
information, see NIH Guide Notice NOT-OD-12-043. The request must be signed by the authorizedBusiness Official and describe the need for additional funding and the categorical costs. In the letter, pointout what will NOT be able to be accomplished if such a request is denied.

2.9 Similar, Essentially Identical, or Identical Applications
Submissions of identical applications to one or more components of the PHS are not allowed.
Submissions of identical applications to one or more components of the PHS are not allowed, and the
NIH will not accept similar grant applications with essentially the same research focus from the same
applicant organization. This includes derivative or multiple applications that propose to develop a single

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product, process or service that, with non-substantive modifications, can be applied to a variety of
purposes. Likewise, identical or essentially identical grant applications submitted by different applicant
organizations will not be accepted. Applicant organizations should ascertain and assure that the materials
they are submitting on behalf of the principal investigator are the original work of the principal
investigator and have not been used elsewhere in the preparation and submission of a similar grantapplication. Applications to the NIH are grouped by scientific discipline for review by individual
Scientific Review Groups and not by disease or disease state. The reviewers can thus easily identify
multiple grant applications for essentially the same project. In these cases, application processing may bedelayed or the application(s) may not be reviewed.
Essentially identical applications will not be reviewed except for: 1) individuals submitting an application
for an Independent Scientist Award (K02) proposing essentially identical research in an application for anindividual research project; 2) individuals submitting an individual research project identical to a
subproject that is part of a program project or center grant application; 3) submissions of applications
previously submitted to an RFA that were not paid or resubmissions of investigator-initiated applications
originally submitted to an RFA (see Grants Policy Statement section 2.3.7.3); and 4) resubmissions ofapplications with a changed grant activity code.

2.10 Submitting Your Application Via Grants.gov
The Authorized Organization Representatives (AORs) registered in Grants.gov are the only official withthe authority to actually submit applications through Grants.gov. Therefore, PD/PIs will need to work
closely with their AOR(s) to determine that all the necessary steps have been accomplished prior to
submitting an application. This includes any internal review process required by the applicant
organization.
Before starting the final submission step, applicants are encouraged to save a copy of the final
application locally. Once you have properly completed all required documents and attached any required
or optional documentation, click on the Check Package for Errors button to ensure that you havesuccessfully completed all Grants.gov required data fields. If any of the required fields are not completed
you will receive an error notice which will indicate where revision is needed within your package. Correct
any errors or if none are found, save the application package. Note that the Check Package for Errors
button only checks a subset of Grants.gov application checks and does not guarantee that your application
will pass subsequent Grants.gov and agency business rule checks done after submission. Only after the
package has been saved with no errors will the Save & Submit button become active. Clicking the Save
& Submit button will begin the application submission process. The application package must then be
saved once more before the submission process begins. Only an AOR will be able to perform the submit
action, and they will be taken to the applicant login page to enter the Grants.gov username and password
that was established in the Register with Grants.gov process (if not connected to the internet you will be
instructed to do so).
Once logged in, the application package will be automatically uploaded to Grants.gov. A confirmation
screen will appear once the upload is complete and a Grants.gov Tracking Number will be provided on
this screen. Applicants should record this number so that they may refer to it should they need to contact
Grants.gov Customer Support or the eRA Commons Help Desk.
For additional information, see http://www.grants.gov/applicants/apply_for_grants.jsp.
Applicants should be aware that on-time submission means that an application is submitted error free (ofboth Grants.gov and eRA Commons errors) before 5 p.m. on the receipt date, local time of the applicant
organization. Applicants are encouraged to submit their applications to Grants.gov several days early toensure enough time to correct any errors before the deadline.

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2.11 After You Submit Your Application Via Grants.gov
Grants.gov’s Track My Application feature for Applicants provides basic status information for a
specified Grants.gov Tracking Number. The Authorized Organization Representative (AOR) can alsologin to Grants.gov with their username and password to obtain a more detailed status of an applicationby using the Check My Application Status feature.
Once an application has been submitted via Grants.gov, several e-mails are sent to the email address on
file with Grants.gov for the AOR (known at NIH/in eRA Commons as the Signing Official [SO]) who
submitted the application. Each email notification will reference a Grants.gov tracking number that is
assigned to the submission:
1)

Submission Receipt: An e-mail is sent indicating your application has been received by Grants.gov
and is currently being validated.

2)

Submission Validation Receipt: An e-mail is sent indicating your application has been received andvalidated by Grants.gov and is being prepared for Grantor agency retrieval.

3)

Grantor Agency Retrieval Receipt: An e-mail is sent indicating your application has been retrievedby the Grantor agency.

4)

Agency Tracking Number Assignment for Application: An e-mail is sent indicating your application
has been assigned an Agency Tracking Number.

If the AOR/SO has not received a confirmation message from Grants.gov within 48 hours of submission,please contact:
Grants.gov Contact Center
Telephone: 1-800-518-4726
E-mail: support@grants.gov
At that point, the application will be scheduled for download into the eRA system for agency validation.
It is imperative that the e-mail address provided for the PD/PI and for the AOR/SO on the SF424 (R&R)
Cover form be current and accurate. Once agency validation is completed, an agency notification (notGrants.gov) will be e-mailed to the PD/PI, AOR/SO, and the Applicant Contact e-mail (if provided)
named in the application.
This e-mail notification will inform the PD/PI, AOR/SO, and the Applicant Contact (if named) that theapplication has been received and processed by the agency and will indicate whether any errors or
warnings resulted during the validation process. The PD/PI, AOR/SO, and the Applicant Contact will be
invited to log on the eRA Commons to view the assembled application or review the list of
warnings/errors that were encountered during the validation process. SOs for the applicant organization,
the PD/PI for the application and any Assistants that have been delegated in eRA Commons to view the
PD/PIs status information will have access to the submission results in eRA Commons.
If there were no validation errors, this e-mail notification will also inform the PD/PI, AOR/SO, and theApplicant Contact of an agency accession number, which represents the “agency tracking number.” This
number replaces the Grants.gov tracking number that was assigned when the application was firstsubmitted. The Grants.gov system will indicate that the agency tracking number has been assigned, andwill reflect both numbers.
The eRA system will make every effort to send an e-mail to the PD/PI, AOR/SO, and the Applicant
Contact summarizing download and validation results. However, since e-mail can be unreliable,
applicants are responsible for checking on their application status in the Commons.

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Once an application package has been successfully submitted through Grants.gov, any encountered errors
have been corrected by the applicant, and an application image has been assembled by the eRA Commons,
PD/PIs and AORs/SOs will have two business days (Monday – Friday, excluding Federal holidays) to checkthe assembled application before it automatically moves forward to NIH staff for further processing andconsideration. Once the application has moved forward, no additional changes to the application will be
accepted through Grants.gov or eRA Commons. This window is known as the application viewing window.
Within the viewing window, SOs have the authority to reject an application to stop it from completing thesubmission process. After an application is rejected, a changed/corrected application can be submitted toaddress warnings or other issues if it is still before the submission deadline. However, changed/corrected
applications submitted after the submission deadline will be subject to the NIH Late Policy and may not be
accepted.
Remember, warnings do not stop further application processing. If an application submission results inwarnings (but not errors), the application will automatically move forward after the application viewing
window if no action is taken. Some warnings may need to be addressed later in the process.
It is your responsibility to view the entire assembled application in eRA Commons and notify the eRA
Commons Help Desk within this window if the assembled application does not correctly reflect the
information submitted to Grants.gov (e.g., submitted information is missing in image, graph/chart appears
upside-down). The eRA Commons Help Desk will provide guidance on appropriate corrective actions.
If you encounter a system issue beyond your control that threatens your ability to complete the submission
process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.
Only the eRA Help Desk can confirm whether a system issue has taken place and provide instructions on
how to resolve the issue. Applications affected by confirmed system issues will not be considered late aslong as the applicant works diligently with the eRA Help Desk on a resolution. If the application needs to be
Rejected and resubmitted, applicants should follow the instructions for correcting errors in Section 2.12,
including the requirement for cover letters on late applications.
PIs should work with their AOR/SO to determine when the “Reject” feature is appropriate.
To view the assembled application the AOR/SO should:
1. Login to the eRA Commons (https://commons.era.nih.gov/commons/) with your Signing
Official (SO) account.
2. Click the Status tab on the Commons menu bar.
3. Click Recent/Pending eSubmissions on the left-hand side of the screen.
4. Search for your application by date received, Grants.gov tracking number, or accession number,to view a hit list of available applications.
5. When you find the appropriate application, click the accession number in the Application ID
column to view the Status Information screen.
6. Click e-Application from the Other Relevant Documents section to view the assembled
application.
Note: The SO can Reject the application by clicking on the Reject eApplication hypertext linkfrom the Action column of the search hit list.
To view the assembled application the PD/PI should:

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1. Login to the eRA Commons (https://commons.era.nih.gov/commons/) with your Principal
Investigator (PI) account.
2. Click the Status tab on the Commons menu bar.
3. Click Recent/Pending eSubmissions near the top of the screen to view a hit list of available
applications.
4. When you find the appropriate application, click the accession number in the Application ID
column to view the status information screen.
5. Click e-Application from the Other Relevant Documents section to view the assembled
application.

2.12 Correcting Errors
Prior to a specified application due date, applicants may make corrections and resubmit an application
through Grants.gov. If applicants make corrections and resubmit the application after the due date, theapplication will be considered late. In this case, applicants must include a cover letter explaining thereasons for the delay and acceptance will be considered on a case-by-case basis. Also see Section 2.14 foradditional information on submission dates.
If errors or warnings result from the validation process, the PD/PI, AOR/SO and Applicant Contact will
be issued an e-mail instructing them to log on to the eRA Commons to review the list of warnings/errorsthat were encountered during the validation process. The eRA system will make every effort to send an email to the PD/PI, AOR/SO and Applicant Contact indicating whether errors or warnings were detected.
However, since e-mail can be unreliable, applicants are responsible for periodically checking on theirapplication status in the eRA Commons, so that any errors or warnings can be resolved in the timeliest
manner possible, before the deadline. SOs for the applicant organization, the PD/PI for the application
and any Assistants that have been delegated in eRA Commons to view the PD/PIs status information will
have access to the submission results in eRA Commons.
Please be aware of the distinction between errors and warnings. The word error is used to characterize
any condition which causes the application to be deemed unacceptable for further consideration.
Generally, errors will indicate significant inaccuracies, inconsistencies, omissions, or incorrect formattingthat have been identified in the body of the application. Conversely, the word warning characterizes any
condition that is acceptable, at least for the time being, but worthy of bringing to the applicant’s attention.
It is at the applicant’s discretion whether a warning condition requires any action, but some warnings mayneed to be addressed later in the process.
Failure to comply with stated NIH policies can also result in a submitted application being returned to theapplicant without being reviewed. For this reason, applicants are strongly encouraged to review all
warnings, to ensure that they require no further attention and that they are satisfied with the validation
results. If desired, warnings can be corrected in the same manner as errors.
A Changed/Corrected application may also be submitted if the PDF image, as viewed in the eRA
Commons, is incomplete or inaccurate from that submitted.
Submitting a Changed/Corrected application will overwrite the previous submission and the previous
application cannot be reinstated.
Errors and warnings may be reviewed in the Commons by performing the following steps:
1. After the application has been downloaded from Grants.gov and validated by the system, login
to the eRA Commons (https://commons.era.nih.gov/commons/) using your username andpassword.

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2. Click the Status tab on the Commons menu bar.
3. Click Recent/Pending eSubmissions.
4. Search for your application by date received, Grants.gov tracking number, or accession number,
if you are the SO. If you are the PI, clicking Recent/Pending eSubmissions will automaticallydisplay a hit list of your applications.
5. A hit list of applications is displayed. If the application was validated with warnings only, orwithout encountering any problems whatsoever, then it is identified in the hit list by its NIH
accession number (e.g., “AN:2911064”). This is the same number that Grants.gov displays, andrefers to as the “agency tracking number.”If any errors were identified during validation, then the application still appears in the hit list,
but in this case it is identified by its Grants.gov tracking number (e.g., “GRANT87654321”).
This is the number that Grants.gov assigned to your application at the time of submission.
6. When you find the appropriate application in the hit list (Application Status will read“eSubmission Error” if errors were received), click its Application ID link to view the list oferrors/warnings.
7. The error/warning page appears, and you are then able to review all conditions that wereidentified during validation. If only warnings were identified, you may elect to take action andresubmit; however you may also disregard the warnings and proceed to view the application, as
described earlier.
To correct errors and resubmit the application:
1. Make whatever corrections are necessary, wherever appropriate, to your local copy of theapplication. Most often this means that you have to edit the data within the application forms tocorrect whatever problem or inconsistency that was noted. Be as careful as possible whencorrecting your application; NIH’s post-submission materials policy does not allow for
applicants to correct oversights in their application after the due date.
2. Check the “Changed/Corrected Application” box in the Type of Submission field of the SF424(R&R) Cover form.
o

If you are submitting this Changed/Corrected application after the due date, be sure to
document the reason for the late submission in the form of a cover letter. NIH makes noguarantees that applications submitted after the due date will be accepted. See the NIH
late policy for more information.

oWhen you check the Changed/Corrected Application box, Previous Grants.gov Tracking
ID field becomes required.

oWhen you have made all of your corrections, save the Changed/Corrected application to
your computer.

3. The AOR will have to submit the Changed/Corrected application package to Grants.gov. A new
Grants.gov tracking number will be assigned and the applicant will have to follow the
Changed/Corrected application through Grants.gov to the eRA Commons to view the application
image or the list of errors/warnings received during the validation process. It is the applicant’s
responsibility to track the application through to the eRA Commons. If you cannot view yourapplication image in the Commons, NIH can’t review your application! Successful submission
may take several rounds of Changed/Corrected applications, since correcting one error may
reveal or create an additional error.

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The same e-mail notifications will be issued once the agency has downloaded and validated the resubmitted application and the PD/PI, AOR/SO, and Applicant Contact will once again be required to log
on to the Commons either to view the application or to review the errors that were encountered during
validation.
The application will only be assigned for scientific review once errors are resolved.
In addition to the validations performed by the eRA system, further administrative review will be
conducted by agency staff. The PD/PI and/or the applicant organization may be contacted for further
corrections/clarifications.

2.13 Post-Submission Application Materials
Grant application materials will only be accepted after submission of the application but before the initialpeer review if they result from unforeseen administrative issues. Exceptions to this policy are indicatedbelow. See NOT-OD-10-091 and NOT-OD-13-030 for additional information.
The materials should be sent as a PDF attachment to an e-mail. E-mail communication is preferred. If email is not feasible, please send in a hard copy.
The original application is kept intact; any application material sent post-submission is sent separately toreviewers. Updated or supplemental grant application materials used in the peer review process will be
retained as part of the official grant file and remain part of the permanent record for that application.
Acceptable post-submission materials include:•

Revised budget page(s) (e.g., change in budget request due to new funding or institutional
acquisition)•

Biographical sketches (e.g., change in senior/key personnel due to the loss of an investigator)•

Letters of support or collaboration resulting from a change in senior/key personnel due to the lossof an investigator•

Adjustments resulting from natural disasters (e.g., loss of an animal colony)•

Adjustments resulting from change of institution (e.g., PI moved to another university)•

News of an article accepted for publication•

News of a professional promotion or positive tenure decision for any Program Directors/Principal
Investigators and Senior/Key Personnel also will be accepted as post-submission applicationmaterial. The news must be received by the Scientific Review Officer one month (30 calendardays) prior to the peer review meeting, and demonstrate concurrence from the Authorized
Organization Representative (AOR) of the applicant organization.

•

If an application proposed to use a human embryonic cell line(s) that is approved by the NIH
Stem Cell Registry at least 30 days prior to the peer review meeting, the SRO can include thisupdate to the reviewers as part of the post-submission materials (see NOT-OD-12-111).

•

Videos, within defined limits, (see, NOT-OD-12-141). Devices and other non-traditional
materials will not be accepted after submission, unless the application is submitted for a Funding
Opportunity Announcement that specifies other types of allowable post-submission materials.

•

For institutional training and training-related grants [not fellowships (F series) or career (Kseries)] applications, the following types of information will be accepted:

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PHS SF424 (R&R) Adobe Forms Version C Application GuideoNews of a trainee's or former trainee's graduation, employment, promotion, funding,publication or other professional achievement since the training grant was submitted;oNews of a faculty member's promotion, funding, publication, or other professional
achievement since the training grant was submitted; andoNews of an additional faculty member who will be involved in the training activity.

Unacceptable post-submission materials [for all applications but those under Exceptions below]
include:•Updated Specific Aims or Research Strategy pages•

Late-breaking research findings•

Supplemental pages - information not contained in the existing application•

New letters of support or collaboration that do not result from a change in senior/key personnel
due to the loss of an investigator

Exceptions to this policy include:•

Applications submitted in response to Requests for Applications (RFAs) that have only one due
date. Post-submission materials for these applications will be accepted as outlined in NOT-OD10-070•

Applications submitted in response to Requests for Applications (RFAs) that have multiple due
dates, the exception to this policy applies to applications submitted for the last due date of an
RFA (see NOT-OD-13-030)•

Applications for training grants (see NOT-OD-10-104)•

Certain NIH Funding Opportunity Announcements (FOAs) may allow certain other types of postsubmission materials to facilitate the goals of the program. Such stipulations must be explained in
the FOA in the NIH Guide for Grants and Contracts

Page limits for post-submission materials under the new policy:•

All post-submission materials must conform to NIH policy on font size, margins, and paper sizeas referenced in Part I.2.6 of the applicable application instructions•

NIH additional form pages such as budget, biographical sketches, and other required forms must
follow NIH standards for required NIH form pages.

•

If post-submission material is not required on a form page, each explanation or letter is limited to
one page (see Acceptable post-submission materials above)•

If the application has subprojects or cores, each subproject or core is allowed explanations or
letters (see Acceptable post-submission materials above), but each explanation or letter is limited
to one pageThe additional materials must be submitted to the NIH SRO with the concurrence of the applicant
organization’s designated AOR/SO. Although the content of post-submission materials may originate
from the PD/PI, Contact PD/PI for multiple PD/PI applications, or organizational officials, the AOR must
send the materials directly to the SRO, or must send his/her concurrence to the PD/PI who will forward
the materials and concurrence to the SRO. A communication from the PD/PI only or with a “cc” to the
AOR will not be accepted.

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The deadline for receipt of additional materials is one month (30 calendar days) prior to the peer review
meeting.
After the initial peer review phase is completed, the NIH Chief Grants Management Officer is the NIH
official responsible for accepting additional materials. Most of the materials submitted after the initialpeer review can be submitted as part of the Just-In-Time process (see Supplemental Instructions Part
III.1.7).

2.14 Application Submission Dates
For submission of applications to NIH, each FOA includes an Opportunity Open Date and an Opportunity
Close Date. Many announcements, including those using the “Standard Submission Dates, include
multiple submission/receipt dates and are active for several years. These announcements are posted in
Grants.gov and the NIH Guide to Grants and Contracts showing an Open/Close period that spans theentire active period of the announcement. Applicants should read the Funding Opportunity
Announcement carefully for specific submission/receipt dates. If specific dates are not referenced in theannouncement, applicants should refer to the Standard Submission Dates for Competing Applications at
this website: http://grants.nih.gov/grants/funding/submissionschedule.htm
Applications submitted for the Standard Submission Dates listed are considered on time if they aresubmitted to Grants.gov on or before 5 p.m. local time on the appropriate date listed. Applications
submitted to FOAs with a single submission date are considered on time if they are submitted toGrants.gov on or before 5 p.m. local time on the appropriate date listed. Applications submitted forSpecial Receipt Dates are considered on time if they are submitted to Grants.gov on or before 5 p.m. local
time on the specified Application Due Date(s). Requests for Applications (RFAs) and Program
Announcements with Special Referral Considerations (PARs) with special receipt dates always must be
received by Grants.gov on the dates designated in the announcement.
Weekend/Federal Holiday Submission Dates. When a postmark/submission date falls on a weekend orFederal holiday, the application deadline is automatically extended to the next business day. If thesubmission deadline shifts beyond the expiration date of the FOA, applicants submitting electronicallymay receive a warning message from Grants.gov. This warning will not keep your application fromprocessing through Grants.gov. As always, applicants must check the eRA Commons to view theirapplication and to ensure they have addressed any errors (instances of non-compliance with NIH businessrules) identified by NIH systems.
Modified Application Submission and Review Policy. A continuous submission process is available toappointed members of chartered standing NIH Study Sections, Boards of Scientific Counselors, Advisory
Boards or Councils, Program Advisory Committees, and peer reviewers who have served as regular or
temporary members of peer review committees six times in 18 months. This alternative submission andreview process is limited to R01, R21, and R34 application that would normally be received on standard
submission dates. See the Peer Review Policies & Practices, Continuous Submission web page for
additional information on the continuous submission process and eligibility requirements.
Late Applications. Permission for a late submission is not granted in advance. In rare cases, lateapplications will be accepted but only when accompanied by a cover letter that details the compelling
reasons for the delay. While the reasons are sometimes personal in nature, an objective evaluation of their
merit requires that some details be provided. Late applications have been accepted for reasons such as:
death of an immediate family member of the PD/PI, sudden acute severe illness of the PD/PI or
immediate family member, or large scale natural disaster.
NIH will consider accepting late applications based on the acceptability of the explanation and theprocessing time required for two different kinds of submission/receipt dates.

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Regular Standard Submission/Receipt Dates: To be considered applications must be received
at the NIH within two weeks of the standard submission date.

•

Expedited Standard Submission/Receipt Dates: To be considered applications must be
received at the NIH within one week of the standard submission date.

•

NIH will not consider late applications for the Special Receipt Dates for RFAs and PARs. This
includes the special receipt dates (March 20, July 20, and November 20) for resubmission
applications that are part of the New Investigator Initiative(http:grants.nih.gov/grants/guide/notice-files/NOT-OD-07-083.html).

•

NIH does not expect to accept any applications received beyond the window of consideration.

The windows of time for consideration of late applications have been carefully chosen so that the lateapplications can be processed with the cohort of on-time applications. In all cases, when the regularstandard submission date or expedited submission date falls on a weekend or federal holiday and isextended to the next business day, the window of consideration for late applications will be calculated
from that business day. Note that the late window always ends in a receipt (not submission) date.
If an application is submitted late, attach a Cover Letter to the SF424 (R&R) cover form using the CoverLetter Attachment field to provide specific information on the timing and nature of the cause of the delay.
No other documentation is expected. Late applications are evaluated on an individual basis considering
the reasons provided. Contacting the Division of Receipt and Referral, Center for Scientific Review(CSR), NIH in advance will not influence the acceptance of a late application.
Related Guide Notices include:•

NOT-OD-12-001 Update of NIH Late Application Policy to Reflect Change in Due Dates for
New Investigator R01 Resubmission Applications at http://grants.nih.gov/grants/guide/noticefiles/NOT-OD-12-001.html;•

NOT-OD-11-035 NIH Policy on Late Submission of Grant Applications at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-035.html; and•NOT-OD-11-093 Change in the NIH Continuous Submission Policy for Reviewers with Recent
Substantial Service at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-093.html.

2.15 Submission, Review and Award Cycles
The PHS submission, review, and award schedule is provided at this website:
http://grants.nih.gov/grants/dates.htm. For specialized grant applications, consult with the appropriate
PHS agency prior to the preparation of an application.
The SF424 (R&R) should only be used for those activity codes where the Application Form is identified
as the SF424 (R&R). Applicants should refer to the OER Applying Electronically website:
http://grants.nih.gov/grants/ElectronicReceipt/ for details on the transition to electronic submission.
Application Assignment Information
Competing grant applications that have been successfully submitted through Grants.gov (including
correcting all errors and the grant application assembled by the eRA Commons system) will be processed
through the Division of Receipt and Referral, CSR, NIH unless otherwise stated. The application will beassigned to an appropriate Scientific Review Group and awarding component(s). Assignment is based on
the scientific content of the application using established referral guidelines. Business rule validations are
conducted by the system as well as NIH staff.

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Assignment to Review Group. The Center for Scientific Review (CSR) will assign appropriately
completed applications to the Scientific Review Groups (commonly referred to as “SRGs” or “study
sections”) that will perform the scientific/technical merit review. The CSR lists the recurring review
panels (http://cms.csr.nih.gov/PeerReviewMeetings/CSRIRGDescription/), and you may suggest a
specific group in the PHS Cover Letter form. See Part I, Section 5.2 of this Guide for a suggested format
for requesting a specific SRG in the Cover Letter.
Assignment to Relevant Potential Awarding Component(s) (ICs). In addition, CSR will assign eachapplication to the agency awarding component that is the potential funding component. When thescientific areas and the research proposed in a grant application are sufficiently relevant to the program
responsibilities of two or more awarding components, CSR may assign your application to all suchcomponents. The component that has the most relevant program responsibility is designated as theprimary assignee. The other components that have an interest in your application are designated as
secondary assignees. If your application is eligible for funding and the primary assignee does not intend
to make an award, the secondary assignees will be given the opportunity to do so. Although thesesuggestions will be taken into consideration, the final determination will be made by the agencies
participating in this solicitation.
After the submission date, usually within two (2) weeks, the PD/PI and the applicant organization will beable to access in the eRA Commons and view the following information regarding the grant application:•

Application assignment number;•Name, address, and telephone number of the Scientific Review Officer (if the review takes placein CSR) of the Scientific Review Group to which the application has been assigned for peer
review; and•Assigned Institute/Center information.

Review outcome and other important information are also available in the Commons.
If assignment information is not available in the eRA Commons within two weeks of the submission date,contact the Division of Receipt and Referral, Center for Scientific Review (CSR), National Institutes of Health,Bethesda, MD 20892-7720, (301) 435-0715; TTY (301) 451-5936. If there is a change in assignment, you will
receive a notification and the change will be reflected in the eRA Commons.
Applicant investigators must not communicate directly with any review group member about anapplication either before or after the review. Failure to strictly observe this policy will create serious
breaches of confidentiality and conflicts of interest in the peer review process. From the time ofassignment to the time the review of your application is complete, applicant investigators must direct allquestions to the Scientific Review Officer. This individual is in charge of the review group and is
identified in the eRA Commons.

2.16 Resources for Finding Help
2.16.1 Finding Help for Grants.gov Registration or Submissions
If help is needed with the Grants.gov registration process or with the technical aspects of submitting anapplication through the Grants.gov system, check first the resources available at Grants.gov(http://grants.gov/).

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Grants.gov customer support is also provided by the following office:Grants.gov Program Management Office
200 Independence Avenue, SW
HHH Building, Room 739F
Washington, DC 20201
Grants.gov Self-Service Web Portal: https://grants-portal.psc.gov/Welcome.aspx?pt=Grants
Grants.gov Help Desk: support@grants.gov
Grants.gov Contact Center Phone Number: 800-518-4726 (Toll Free)
606-545-5035 (Local or International)
The Contact Center is available 24 hours a day, 7 days a week (except Federal holidays).

2.16.2 Finding Help for the eRA Commons Registration oreRA Commons Validation Processes
If help is needed with the eRA Commons registration process for the applicant organization and PD/PIs;
with using ASSIST for the preparation and submission of multi-project applications; or with theapplication validation process in the Commons after submission through Grants.gov, check first theresources available at the Applying Electronically website:(http://grants.nih.gov/grants/ElectronicReceipt/).
eRA Commons customer support is also provided by the eRA Commons Help Desk:eRA Website: http://era.nih.gov
eRA Commons Website: https://commons.era.nih.gov/commons/index.jsp
eRA Commons On-line Resources and Web Ticketing: http://era.nih.gov/help/
eRA Commons Help Desk E-mail: commons@od.nih.gov
eRA Commons Phone:301-402-7469
866-504-9552 (Toll Free)
301-451-5939 (TTY)

The eRA Commons Help Desk hours of operation are Monday-Friday from 7:00 a.m. to 8:00 p.m.
Eastern Time (except Federal holidays).
NOTE: To help expedite your Help Desk request, we recommend that you have the following information
readily available (NOTE: Additional details may be required depending upon the type of issue/request):•

Full Name of Affected User•

Full Name of Institution/Organization•

Grants.gov Tracking Number•

Submission Date•

Funding Opportunity Announcement (FOA)•

Principal Investigator’s (PI) Username•

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2.16.3 Finding Help for Application Preparation
If after reviewing this application instruction guide, help is still needed in preparing the application,
contact GrantsInfo:
GrantsInfo Phone:301-435-0714
301-451-5936 (TTY)

GrantsInfo E-mail:

GrantsInfo@nih.gov

3.

Using the Grant Application Package

This section describes the steps an applicant takes once the appropriate FOA (see Section 2.4) has been
located and the corresponding grant application package has been successfully downloaded.

3.1 Verify Grant Information
When you select a funding opportunity in Grants.gov Apply, verify that the information shown in the
Grant Application Package screen corresponds to the funding opportunity for which you wish to apply.
Grants.gov auto-populates the following information:•

Opportunity Title•

Offering Agency•

CFDA Number•

CFDA Description•

Opportunity Number•

Competition ID•

Opportunity Open Date•

Opportunity Close Date•

Agency Contact

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CFDA Number Field: Many FOAs include multiple CFDA (Catalog for Domestic Assistance) numbers.
When this is the case, the CFDA Number and CFDA Description fields will appear blank in the
Grants.gov Grant Application Package screen shown above. The appropriate CFDA number will be
automatically assigned once the application is assigned to the appropriate agency awarding component.
Opportunity Open Date & Close Date Fields: Many FOAs posted by NIH and other PHS agencies
include multiple submission/receipt dates and are active for several years. These announcements areposted in Grants.gov showing an Open/Close period that spans the entire active period of theannouncement. Applicants should read the funding opportunity announcement carefully for specificsubmission/receipt dates. If specific dates are not referenced in the announcement, applicants should referto the PHS submission, review, and award schedule at http://grants.nih.gov/grants/dates.htm. Applications
submitted after a posted submission date will normally not be held over into the next review cycle.
Instead, the PD/PI will be notified and will have to submit the application again. See Part I, Section 2.14of this Guide for more information on the late application policy.

3.2 Enter the Name for the Application
Enter a name for the application in the Application Filing Name field (this is a required field). This nameis for use solely by the applicant for tracking the application through the Grants.gov submission process.
It is not used by the receiving agency.

3.3 Open and Complete Mandatory Documents
Click the form name to navigate to the form in the application package and complete all of the Mandatory
forms. Complete the form titled SF424 (R&R) first. Data entered in this form populates othermandatory and optional forms where applicable.

3.4 Open and Complete Optional Documents
These documents can be used to provide additional information for the application or may be required forspecific types of grant activities. Information on each of these documents is found later in thesePart I: Instructions for Preparing and Submitting an Application

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instructions. In some application packages applicants will see two budget options; e.g., Research &Related Budget and PHS 398 Modular Budget in the Optional Documents section. While both appear as
Optional Documents, one or the other will always be required. See Section 4.6 Selecting the Appropriate
Budget Form for additional details.
Click the check box next to the form name to add the form to the application package. To navigate to theform, click on the form name. To remove an optional form from the application package, uncheck the box
next to the form name.

3.5 Submitting the Application via Grants.gov
Once you have properly completed all required documents and attached any required or optional
documentation, click on the Check Package for Errors button to ensure that you have successfullycompleted all required data fields. If any of the fields required by Grants.gov are not completed you will
receive an error notice which will indicate where revision is needed within your package. Correct any
errors or if none are found, save the application package. The Save & Submit button will now become
active and clicking this button will begin the application submission process. Only after the package has
been saved with no errors will the Save & Submit button become active. The application package mustthen be saved once more before the submission process begins. Only an AOR will be able to perform thesubmit action, and they will be taken to the applicant login page to enter the Grants.gov username andpassword that was established in the Grants.gov registration process (if not connected to the internet you
will be instructed to do so).

4.

Completing the SF424 Research and Related(R&R) Forms

4.1 Overview
This section contains all of the instructions you will need to complete the SF424 (R&R) forms.
Any agency-specific instructions on SF424 (R&R) forms used federal-wide are denoted by the
DHHS logo displayed to the left of the paragraph, as illustrated here.
Conformance to all instructions is required and strictly enforced. Agencies may withdraw any
applications from the review process that are not consistent with these instructions.
As you navigate through the Grants.gov forms, required fields are highlighted and outlined in red.
Optional fields and completed fields are displayed in white. Data entered into a specific field is not
accepted until you have navigated to the next field. If you enter invalid or incomplete information in afield, you will receive an error message.
Note the highlighted fields required for submissions, and the Check Package for Errors button,
only refer to Grants.gov requirements and errors. They do not reflect all agency requirements orPart I: Instructions for Preparing and Submitting an Application

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PHS business processes. Agency validations will be performed by the eRA Commons systemafter the application has been submitted.
For those forms that are more than one page, click the Next button at the top of the form or scroll down
(using the scroll bar on the right hand side of the screen) to navigate to a subsequent page. Once all data
have been entered scroll up using the scroll bar to return to the Grant Application Package Screen.

4.2 Cover Form

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1. Type of Submission
Check one of the Type of Submission boxes. If this submission is to change or correct a previously
submitted "New", "Resubmission", "Renewal", or "Revision" application, click the Changed/Corrected
Application box and enter the Grants.gov tracking number in the Previous Grants.gov Tracking ID field.
Unless requested by the agency, applicants may not use this to submit changes after the closing date. This
field is required.
Pre-Application: Unless specifically noted in a program announcement, the Pre-application
option is not used by NIH and other PHS agencies.
Changed/Corrected Application: This box must be used if you need to submit the same
application again to correct system validation errors, application assembly problems, or toincorporate other changes. When submitting a Changed/Corrected Application:
•
•

•
•

If submitting after the submission date, include an explanation in the Cover Letter Form.
Submitting a Changed/Corrected application replaces the previous submission and removes
the previous submission from consideration. Once an application has moved forward toagency staff following the two-day application viewing window, subsequent
Changed/Corrected applications will not be accepted unless the application is withdrawn.
Note that if you are submitting additional grant application materials after the submission
date some special guidelines may apply. See NIH Guide Notice NOT-OD-10-115(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-115.html) for the NIH Policy on
Post-Submission Application Materials.
When you check the Changed/Correct Application box the Previous Grants.gov Tracking ID
becomes a required field.
Do not use the Changed/Corrected Application box to denote a submission of a resubmission
or amended application. That will be indicated in the Type of Application.

2. Date Submitted and Applicant IdentifierEnter the date the application is submitted to Federal agency (or State if applicable). In the applicant
identifier field enter the applicant’s control number (if applicable).
Note the Applicant Identifier field is a control number created by the applicant organization, notthe Federal agency.
3. Date Received by State and State Application IdentifierEnter the date received by state (if applicable). In the State Application Identifier field, enter the state
application identifier, if applicable.
For submissions to NIH and other PHS agencies, leave these fields blank.
4.a. Federal Identifier
When a New Application is being submitted following a Pre-Application, enter the agency-assigned preapplication number, if applicable. If this is a continuation, revision, or renewal application, enter theassigned Federal Identifier number (for example, award number)--even if submitting a
Changed/Corrected application.
For submissions to NIH and other PHS agencies, include only the IC and serial number of thepreviously assigned application/award number (e.g., use CA987654 from 1R01CA987654-01A1).
The Federal Identifier is required for Resubmission, Renewal, and Revision applications.
Existing definitions for NIH and other PHS agencies applications are somewhat different:Part I: Instructions for Preparing and Submitting an Application

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•

•

•
•

•

New is the same; i.e., an application that is submitted for the first time. See also the policy
Resubmission of Unpaid RFA Applications and Resubmission of Applications with a
Changed Grant Activity Code.
Resubmission is equivalent to NIH and other PHS agencies Revision. Check this option whensubmitting a revised (altered or corrected) or amended application. See also the NIH Policy
on Resubmission Applications. Institutions submitting revision or renewal applications thatare also resubmissions (A1 or A2 if allowed, see NIH Grant Notice NOT-OD-09-003,
http://grants.nih.gov/grants/guide/notice-files/not-od-09-003.html) are instructed to select“Resubmission.” For additional information, see NIH Guide Notice NOT-OD-10-052,
http://grants.nih.gov/grants/guide/notice-files/not-od-10-052.html).
Renewal is equivalent to NIH and other PHS agencies Competing Continuation.
Continuation is equivalent to NIH and other PHS agencies Progress Report. For the purposes
of NIH and other PHS agencies, the box for Continuation will not be used and should not bechecked.
Revision is somewhat equivalent to NIH and other PHS agencies Competing Supplement, but
proposes a change in 1) the Federal Government’s financial obligations or contingent liability
from an existing obligation, or 2) any other change in the terms and conditions of the existing
award. In general, changes to the “terms and conditions of the existing award” would not
require the submission of another application through Grants.gov. Applicants should contact
the awarding agency for advice on submitting any revision/supplement application.

Applicants to NIH and other PHS agencies should complete this field when submitting a
resubmission, renewal or revision application. When submitting a “New” application, this fieldshould remain blank4.b. Agency Routing IdentifierEnter the agency-assigned routing identifier per the agency-specific instructions. This is an optional field.
Unless specifically noted in a program announcement, the Agency Routing Identifier is not used by NIH
or other PHS agencies.
4.c. Previous Grants.gov Tracking ID
Enter the previous Grants.gov tracking number, if applicable.
5. Applicant Information
This information is for the Applicant Organization, not a specific individual.

Field Name

Instructions

Organizational DUNSEnter the DUNS or DUNS+4 number of the applicant organization. This
field is required.
For submission to NIH and other PHS agencies, this DUNS
must match the number entered in the eRA Commons
Institutional Profile for the applicant organization. The applicant
AOR is encouraged to confirm that a DUNS has been entered in
the eRA Commons Institutional Profile (IPF) prior to submitting
an application. If your organization does not already have a
DUNS number, you will need to go to the Dun & Bradstreet
website at http://fedgov.dnb.com/webform to obtain the number.

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Field Name

Instructions
The same DUNS should be used in the eRA Commons IPF,
Grants.gov registration and in the DUNS field in the application.

Legal NameEnter the legal name of the applicant which will undertake the assistanceactivity, enter the complete address of the applicant (including
county/parish and country), and name, telephone number, e-mail, andfax of the person to contact on matters related to this application.

Department

Enter the name of the primary organizational department, service,laboratory, or equivalent level within the organization that will undertakethe assistance activity.

DivisionEnter the name of the primary organizational division, office, or major
subdivision which will undertake the assistance activity.

Street1

Enter the first line of the street address for the applicant in “Street1”
field. This field is required.

Street2Enter the second line of the street address for the applicant in “Street2”
field. This field is optional.

City

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

County/Parish

Enter the county/parish for address of applicant.

StateEnter the State where the applicant is located. This field is required if theapplicant is located in the United States.

ProvinceEnter the Province.
If “Country” is not Canada, please leave blank.

Country

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

ZIP CodeEnter the nine-digit Postal Code (e.g., ZIP code) of applicant. This fieldis required if the applicant is located in the United States. This field is
required if a State is selected; optional for Province.

Person to be contacted on matters involving this application:
This information is for the Administrative or Business Official, not the PD/PI. This person is theindividual to be notified if additional information is needed and/or if an award is made. To avoid
potential errors and delays in processing, please ensure that the information provided in thissection is identical to the AO profile information contained in the eRA Commons.
Field Name

Instructions

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Field Name

Instructions

PrefixThe Project Director/Principal Investigator (PD/PI) is the individual
responsible for the overall scientific and technical direction of the
project. Enter the prefix (e.g., Mr., Mrs., Rev.) for the name of the
PD/PI.

First NameEnter the first (given) name of the person to contact on matters related tothis application. This field is required.

Middle NameEnter the middle name of the person to contact on matters related to thisapplication.

Last NameEnter the last (family) name of the person to contact on matters related
to this application. This field is required.

SuffixEnter the suffix (e.g., Jr., Sr., Ph.D.) for the person to contact on mattersrelated to this application.

Position/Title

Enter the Position/Title for the person to contact on matters related tothis application.

Street 1

Enter the first line of the street address for the applicant in “Street1”
field. This field is required.

Street 2

Enter second line of the street address of the person to contact on mattersrelated to this application. This field is optional.

City

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

County/Parish

Enter the county/parish of the person to contact on matters related to thisapplication.

State

Enter the State where the applicant is located. This field is required if theapplicant is located in the United States.

ProvinceEnter the Province.
If “Country” is not Canada, please leave blank.

CountySelect the country for the applicant address. This field is required.

ZIP CodeEnter the nine-digit Postal Code (e.g., ZIP code) of applicant. This fieldis required if the applicant is located in the United States. This field is
required if a State is selected; optional for Province.

Phone NumberEnter the daytime phone number for the person to contact on mattersrelated to this application. This field is required

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Field Name

Instructions

Fax

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

EmailEnter the e-mail address for the person to contact on matters related tothis application

6. Employer Identification
Enter either TIN or EIN as assigned by the Internal Revenue Service. If your organization is not in the
U.S., enter 44-4444444. This field is required.
If you have a 12-digit EIN established for grant awards from NIH or other PHS agencies, enterall 12 digits (e.g., 1123456789A1); this includes non-U.S. organizations.
7. Type of Applicant
This information is for the Applicant Organization, not a specific individual AOR or PD/PI.
Field Name

Instructions

Type of Applicant

Select the appropriate applicant type code. If Small Business is selected
as Type of Applicant, then note if the organization is Woman-owned
and/or Socially and Economically Disadvantaged. This field is required.
For eligible Agencies of the Federal Government, select X:
Other (specify), and then indicate the name of the appropriate
Federal agency in the space below.

Other (Specify)

Complete only if “Other” is selected as the Type of Applicant.

Woman Owned

Check if you are a woman-owned small business – a small business thatis at least 51% owned by a woman or women, who also control andoperate it.

Socially and Economically
Disadvantaged

Check if you are a socially and economically disadvantaged small
business, as determined by the U.S. Small Business Administration
pursuant to Section 8(a) of the Small Business Act U.S.C. 637(a).

8. Type of Application
Field Name

Instructions

Type of Application

Select the type from the following list. Check only one. This field is
required.
••

New: An application that is being submitted to an agency forthe first time.
Resubmission: An application that has been previously
submitted, but was not funded, and is being resubmitted for
new consideration.

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Field Name

Instructions
Renewal: An application requesting additional funding for aperiod subsequent to that provided by a current award. A
renewal application competes with all other applications andmust be developed as fully as though the applicant isapplying for the first time.
• Continuation: A non-competing application for an additional
funding/budget period within a previously approved project
period.
• Revision: An application that proposes a change in1) the Federal Government’s financial obligations or contingent
liability from an existing obligation, or2) any other change in the terms and conditions of the existing award.
•

Existing definitions for NIH and other PHS agencies Type ofApplication are somewhat different:
•

•

•
•

•

New is the same. Check this option when submitting anapplication for the first time. See also the policy
Resubmission of Unpaid RFA Applications andResubmission of Applications with a Changed Grant
Activity Code.
Resubmission is equivalent to NIH and other PHS agencies
Revision. Check this option when submitting a revised(altered or corrected) or amended application. See also the
NIH Policy on Resubmission Applications. Institutions
submitting revision or renewal applications that are also
resubmissions (A1 or A2 if allowed, see NIH Grant Notice
NOT-OD-09-003, http://grants.nih.gov/grants/guide/noticefiles/not-od-09-003.html) are instructed to select“Resubmission.” For additional information, see NIH Guide
Notice NOT-OD-10-052,
http://grants.nih.gov/grants/guide/notice-files/not-od-10052.html).
Renewal is equivalent to NIH and other PHS agencies
Competing Continuation.
Continuation is equivalent to NIH and other PHS agencies
Progress Report. For the purposes of NIH and other PHS
agencies, the box for Continuation will not be used andshould not be checked.
Revision is somewhat equivalent to NIH and other PHS
agencies Supplement, but would also include other changes
as noted in the definition above. In general, changes to the“terms and conditions of the existing award” (as noted inexample 2 above) would not require the submission ofanother application through Grants.gov. Applicants should
contact the awarding agency for advice on submitting any
revision/supplement application.

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Field Name

Instructions
This field also affects how you complete the Federal Identifier.
If “Type of Application” is “New”, you can leave the Federal
Identifier field blank unless otherwise specified in the funding
opportunity announcement.
If “Type of Application” is “Renewal,” “Revision,” or“Resubmission,” enter the IC and serial number of thepreviously assigned application/award number (e.g., use
CA987654 from 1R01CA987654-01A1).

If Revision, markappropriate box(es)If Revision, mark appropriate box(es). May select more than one:
A. Increase Award
B. Decrease Award
C. Increase Duration
D. Decrease Duration
E. Other
If “Other” is selected, please specify in the text box provided.
For the purposes of NIH and other PHS agencies, the boxes for
options B, C, D, and E will generally not be used and should not
be selected unless specifically addressed in a particular FOA.

Other

If “Other” is selected for Revision, add text to explain.

Is this application being
submitted to other agencies?

Check box if applicable. One selection is required.

What Other Agencies?

Enter Agency name.

In the field “Is this application being submitted to otheragencies?,” please check the box “yes” if one or more of thespecific aims submitted in your application are also contained ina similar, identical, or essentially identical application submitted
to another Federal agency. Indicate the agency or agencies towhich the application has been submitted. For additional
information, please see NIH Guide Notice NOT-OD-09-100,
Reminder and Clarification of NIH Policies on Similar,
Identical, or Essentially Identical Applications, Submission ofApplications Following RFA Review, and Submission ofApplications with a Changed Activity Code,
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09100.html.

9. Name of Federal Agency
Name the Federal agency from which assistance is being requested with this application. This field is prepopulated from the opportunity package.

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10. Catalog of Federal Domestic Assistance (CFDA) Number and Title (CFDA)
This is the Catalog of Federal Domestic Assistance number of the program under which assistance isrequested. This field is pre-populated from the opportunity package.
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 field will not allow any data entry. The
appropriate CFDA number will be automatically assigned by the agency once the application is
assigned to the appropriate awarding component.
11. Descriptive Title of Applicant’s ProjectEnter a brief descriptive title of the project. This field is required.
A “new” application must have a different title from any other PHS project with the same PD/PI.
A “resubmission” or “renewal” application should normally have the same title as the previous
grant or application. If the specific aims of the project have significantly changed, choose a newtitle.
A “revision” application must have the same title as the currently funded grant.
NIH and other PHS agencies limit title character length to 81 characters, including the spaces
between words and punctuation. Titles in excess of 81 characters will be truncated. Be sure to
only use standard characters in the descriptive title: A through Z, a through z, 0 through 9, space( ), and underscore (_).
12. Proposed ProjectStart Date: Enter the proposed start date of the project. This field is required.
Ending Date: Enter the proposed end date of the project. This field is required.
13. Congressional District of Applicant
Enter the Congressional District in the format: 2 character State Abbreviation – 3 character District
Number. Examples: CA-005 for California’s 5th district, CA-012 for California’s 12th district.
If outside the U.S., enter 00-000.
To locate your congressional district, visit the Grants.gov website.
For States and U.S. territories with only a single congressional district enter “001” for the districtcode. For jurisdictions with no representative, enter “099”. For jurisdictions with a nonvoting
delegate, enter “098” for the district number. Example: DC-098, PR-098.

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14. Program Director/Principal Investigator (PD/PI) Contact Information
If submitting an application reflecting Multiple PD/PIs, the individual designated as the Contact
PI must be affiliated in the Commons with the applicant organization and should be entered here.
See Section 4.5 Senior/Key Person Profile Forms for additional instructions for Multiple PD/PIs.
To avoid potential errors and delays in processing, please ensure that the information provided inthis section is identical to the PD/PI profile information contained in the eRA Commons.
Field Name

Instructions

PrefixThe Project Director/Principal Investigator (PD/PI) is the individual
responsible for the overall scientific and technical direction of the
project. Enter the prefix (e.g., Mr., Mrs., Rev.) for the name of the
PD/PI.

First NameEnter the first name of the PD/PI. This field is required.

Middle NameEnter the middle name of the PD/PI.

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

SuffixEnter the suffix (e.g., Jr., Sr., Ph.D) of the PD/PI.
Do not use this field to record degrees. Degrees for the PD/PI
are requested separately in the Senior/Key Person Profile.

Position/Title

Enter the position/title of the PD/PI.

Organization NameEnter the name of organization for the PD/PI. This field is required.

Department

Enter the name of primary organizational department, service,laboratory, or equivalent level within the organization of the PD/PI.

DivisionEnter the name of primary organizational division, office, or major
subdivision of the PD/PI.

Street1

Enter first line of the street address for the PD/PI in the “Street1” field.
This field is required.

Street2Enter the second line of the street address for the PD/PI in the “Street2”
field. This field is optional.

City

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

County/Parish

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

StateEnter the State where the PD/PI is located. This field is required if the
PD/PI is located in the United States.

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Field Name

Instructions

ProvinceEnter the province for PD/PI.
If “Country” is not Canada, please leave blank.

Country

Select the country for the PD/PI address.

ZIP/Postal CodeEnter the Postal Code (e.g., ZIP code) of the PD/PI. This field is
required if the PD/PI is located in the United States.
A nine-digit Zip code is required.

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

Fax NumberEnter the fax number for the PD/PI.

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

15. Estimated Project Funding
Field Name

Instructions

a. Total Federal Funds
Requested

Enter total Federal funds requested for the entire project period. This
field is required.
Please ensure number(s) complies with application
requirements.

b. Total Non-Federal Funds

Enter total non-Federal funds proposed for the entire project period. This
field is required.
For NIH and other PHS agencies, enter “0” in this field unlesscost sharing is a requirement for the specific announcement.

c. Total Federal & NonFederal Funds

Enter total estimated funds for the entire project period, including bothFederal and non-Federal funds. This field is required.
For NIH and other PHS agencies applicants, this field will be thesame as Total Federal Funds Requested above unless the
specific announcement indicates that cost sharing is arequirement.

d. Estimated Program
IncomeIdentify any Program Income estimated for this project period if
applicable. This field is required.

16. Is Application Subject to Review by State Executive Order 12372 Process?
If yes, check box. If the announcement indicates that the program is covered under Executive Order
12372, applicants should contact the State Single Point of Contact (SPOC) for Federal Executive Order
12372. If no, check appropriate box. One selection is required.

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If block 16a is checked, insert date application was submitted to State.
For NIH and other PHS agencies submissions using the SF424 (R&R), applicants should check“No, Program is not covered by E.O. 12372.”
17. Certification
Check “I agree” to provide the required certifications and assurances. This field is required.
The list of NIH and other PHS agencies Assurances, Certifications, and other Policies is found in
Supplemental Instructions Part III, Policies, Assurances, Definitions, and Other Information.
The applicant organization is responsible for verifying its eligibility and the accuracy, validity,
and conformity with the most current institutional guidelines of all the administrative, fiscal, andscientific information in the application, including the Facilities and Administrative rate.
Deliberate withholding, falsification, or misrepresentation of information could result in
administrative actions, such as withdrawal of an application, suspension and/or termination of anaward, debarment of individuals, as well as possible criminal penalties. The signer further
certifies that the applicant organization will be accountable both for the appropriate use of any
funds awarded and for the performance of the grant-supported project or activities resulting fromthis application. The grantee institution may be liable for the reimbursement of funds associatedwith any inappropriate or fraudulent conduct of the project activity.
18. SFLLL (Disclosure of Lobbying Activities) or Other Explanatory Documentation
If applicable, attach the SFLLL or other explanatory document per agency instructions.
If unable to certify compliance in with the Certification above attach an explanation.
Additionally, as applicable, attach the SFLLL (Standard Form LLL, Disclosure of Lobbying
Activities) or other documents in this item. A fillable version of the SFLLL form is available at
http://www.whitehouse.gov/omb/assets/omb/grants/sflllin.pdf.
19. Authorized Representative
This is equivalent to the individual with the organizational authority to sign for an application;otherwise known as the Authorized Organization Representative or the Signing Official.
Field Name

Instructions

PrefixEnter the prefix (Mr., Mrs., Rev.) for the name of the Authorized
Representative.

First NameEnter the first (given) name of the Authorized Representative. This fieldis required.

Middle NameEnter the middle name of the Authorized Representative.

Last NameEnter the last (family) name of the Authorized Representative. This fieldis required.

SuffixEnter the suffix (e.g., Jr., Sr., Ph.D.) for the name of the Authorized
Representative.

Position/Title

Enter the title of the Authorized Representative. This field is required.

Organization

Enter the name of the organization for the Authorized Representative.

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Field Name

Instructions
This field is required.

Department

Enter the name of the primary organizational department, service,laboratory, or equivalent level within the organization of the Authorized
Representative.

DivisionEnter the name of the primary organizational division, office, or major
subdivision of the Authorized Representative.

Street1

Enter the first line of the street address for the Authorized Representativein the “Street1” field. This field is required.

Street2Enter the second line of the street address for the Authorized
Representative in the “Street2” field. This field is optional.

City

City for address of the Authorized Representative. This field is required.

County/Parish

Enter the county/parish for address of the Authorized Representative.

State

Enter the state where the Authorized Representative is located. This fieldis required if the Authorized Representative is located in the UnitedStates.

ProvinceEnter the Province for the Authorized Representative.
If “Country” is not Canada, please leave blank.

Country

Select the country for the Authorized Representative address.

ZIP/Postal CodeEnter Postal Code (e.g., ZIP code) of the Authorized Representative.
This field is required if the Authorized Representative is located in the
United States.
A nine-digit Zip code is required.

Phone NumberEnter the daytime phone number for the Authorized Representative. This
field is required.

Fax NumberEnter the fax number for the Authorized Representative.

E-mailEnter the e-mail address for the Authorized Representative. This field is
required.

Signature of Authorized
Representative

It is the organization’s responsibility to assure that only properly
authorized individuals sign in this capacity and/or submit the application
to Grants.gov. If this application is submitted through Grants.gov, leave

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Field Name

Instructions
blank. If a hard copy is submitted, the AOR must sign this block.

Date Signed

If this application is submitted through Grants.gov, the system will
generate this date. If submitting a hard copy, enter the date the AOR
signed the application.

20. Pre-Application
If submitting a pre-application, provide a summary description of the project in accordance with theannouncement and/or agency specific instructions, and save the file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, and then click Open.
Unless specifically noted in a program announcement, NIH and other PHS agencies do not use
Pre-applications.
21. Cover Letter Attachment
Attach the cover letter in accordance with the announcement and/or the agency specific instructions.
Applicants are encouraged to include a cover letter with the application. The cover letter is only
for internal use and will not be shared with peer reviewers. The letter should contain any of thefollowing information that applies to the application:
1. Application title.
2. Funding Opportunity (PA or RFA) title of the NIH initiative.
3. Request of an assignment (referral) to a particular awarding component(s) or Scientific
Review Group (SRG). The PHS makes the final determination.
4. List of individuals (e.g., competitors) who should not review your application and why.
5. Disciplines involved, if multidisciplinary.
6. For late applications (see Late Application policy in Section 2.14) include specificinformation about the timing and nature of the cause of the delay.
7. When submitting a Changed/Corrected Application after the submission date, a cover letter isrequired explaining the reason for the Changed/Corrected Application. If you alreadysubmitted a cover letter with a previous submission and are now submitting a
Changed/Corrected Application, you must include all previous cover letter text in the revised
cover letter attachment. The system does not retain any previously submitted cover letters;
therefore, you must repeat all information previously submitted in the cover letter as well as
any additional information.
8. Explanation of any subaward budget components that are not active for all periods of the
proposed grant.
9. Statement that you have attached any required agency approval documentation for the type of
application submitted. This may include approval for applications $500,000 or more,
approval for Conference Grant or Cooperative Agreement (R13 or U13), etc.
Suggested Cover Letter Format
The Division of Receipt and Referral (DRR), Center for Scientific Review (CSR) is responsible
for assigning applications to ICs and to Scientific Review Groups (SRGs). DRR will be utilizing

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knowledge management approaches as an adjunct to the work of referral experts as part of an
overall plan to shorten the time from submission to review. Analysis has shown that requests
made by investigators are a valuable source of information in this process. In order to facilitate
the use of these requests in conjunction with knowledge management analysis of the content of
the application, applicants are requested to use the following format when assignment requests
are contained in a cover letter.
•

List one request per line.

•

Place Institute/Center (IC) and SRG review requests (if both are made) on separate lines.

•

Place positive and negative requests (if both are made) on separate lines.

•

Include name of IC or SRG, followed by a dash and the acronym. Do not use
parentheses.

•

Provide explanations for each request in a separate paragraph.

Examples:Please assign this application to the following:
Institutes/Centers
National Cancer Institute - NCI
National Institute for Dental and Craniofacial Research – NIDCR
Scientific Review Groups
Molecular Oncogenesis Study Section – MONC
Cancer Etiology Study Section – CE
Please do not assign this application to the following:
Scientific Review Groups
Cancer Genetics Study Section – CG
The reasons for this request are [provide a narrative explanation for the request(s)].

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4.3 Project/Performance Site Locations Form

Indicate the primary site where the work will be performed. If a portion of the project will be performedat any other site(s), identify the site location(s) in the blocks provided.
Project/Performance Site Primary Location
Generally, the Primary Location should be that of the applicant organization or identified as offsite in accordance with the conditions of the applicant organization’s negotiated Facilities andAdministrative (F&A) agreement. This information must agree with the F&A information on the
Cover Page Supplement Form of the application. If there is more than one performance site,
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fields provided for Location 1 - # below. Applicants should also provide an explanation of
resources available from each Project/Performance Site, the Facilities and Resources attachmentof the Other Project Information form, and describe any consortium/contractual arrangements in
the Consortium/Contractual Arrangements attachment of the PHS 398 Research Plan.
Unless otherwise instructed in a FOA, do not check the “I am submitting an application as anindividual, and not on behalf of a company, state, local or tribal government, academia, or othertype of organization” box.
If a Project/Performance Site is engaged in research involving human subjects, the applicant
organization is responsible for ensuring that the Project/Performance Site operates under anappropriate Federal Wide Assurance for the protection of human subjects and complies with 45
CFR part 46 and other NIH human subject related policies described in Supplemental Instructions
Part II of this Application Guide and in the NIH Grants Policy Statement.
For research involving live vertebrate animals, the applicant organization must ensure that all
Project/Performance Sites hold an OLAW-approved Animal Welfare Assurance. If the applicant
organization has neither an animal care and use program, facilities to house animals and conduct
research on site, nor an IACUC, and the animal work will be conducted at an institution with an
Animal Welfare Assurance, the applicant must obtain an Inter-institutional Assurance from
OLAW prior to an award.
Field Name

Instructions

Organization Name

Indicate the organization name of the primary site where the work will
be performed. If a portion of the project will be performed at any othersites(s), identify the site location(s) in the block(s) provided.

DUNS NumberEnter the DUNS number associated with the organization where theproject will be performed.
The DUNS Number is a required field for the Primary
Performance Site.

Street1

Enter first line of the street address in "Street 1" field of the primaryperformance site location. This field is required.

Street2Enter second line of the street address in "Street 2" field for the primaryperformance site location. This field is optional.

City

Enter the City for address of the primary performance site location. This
field is required.

CountyEnter the County of the primary performance site location.

State

Enter the State where the primary performance site location is located.
This field is required if the Project Performance Site is located in the
United States..

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Field Name

Instructions

ProvinceEnter the province of the primary performance site location.
If “Country” is not Canada, please leave blank.

Country

Select the Country of the Primary Performance Site location. This fieldis required.

ZIP CodeEnter the nine-digit Postal Code (e.g., ZIP code) of the performance site
location. This field is required if the performance site location is in the
United States.
A nine-digit Zip code is required.

Project/Performance Site
Congressional District

Enter the Congressional District in the format: 2 character State
Abbreviation – 3 character District Number. Examples: CA-005 for
California’s 5th district, CA-012 for California’s 12th district.
If all districts in a state are affected, enter “all” for the district number.
Example MD-all for all congressional districts in Maryland.
If nationwide (all districts in all states), enter US-all.
If the program/project is outside the U.S., enter 00-000.
To locate your congressional district, visit the Grants.gov website. Note
it is likely this field will be identical to the “Congressional District ofApplicant” field provided elsewhere in the application.
For States and U.S. territories with only a single congressional
district enter “001” for the district code. For jurisdictions withno representative, enter “099”. For jurisdictions with anonvoting delegate, enter “098” for the district number.
Example: DC-098, PR-098.

Project/Performance Site Location 1
Field Name

Instructions

Organization Name

Indicate the organization name of the primary site where the work will
be performed. If a portion of the project will be performed at any othersites(s), identify the site location(s) in the block(s) provided.

DUNS NumberEnter the DUNS number associated with the organization where theproject will be performed. This field is optional.

Street1

Enter first line of the street address in "Street 1" field of the primaryperformance site location. This field is required.

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Field Name

Instructions

Street2Enter second line of the street address in "Street 2" field for the primaryperformance site location. This field is optional.

City

Enter the City of the performance site location. This field is required.

CountyEnter the County of the performance site location.

State

Enter the State where the primary performance site location is located.
This field is required if the Project Performance Site is located in the
United States.

ProvinceEnter the Province where the primary performance site location is
located.
If “Country” is not Canada, please leave blank.

Country

Select the name of the country for the primary project performance site.

ZIP CodeEnter the nine-digit Postal Code (e.g., ZIP code) of the primaryperformance site location. This field is required if the Project
Performance Site is located in the United States.

Project/Performance Site
Congressional District

Enter the Congressional District in the format: 2 character State
Abbreviation – 3 character District Number. Examples: CA-005 for
California’s 5th district, CA-012 for California’s 12th district.
If all districts in a state are affected, enter “all” for the district number.
Example MD-all for all congressional districts in Maryland.
If nationwide (all districts in all states), enter US-all.
If the program/project is outside the U.S., enter 00-000.
To locate your congressional district, visit the Grants.gov website. Note
it is likely this field will be identical to the “Congressional District ofApplicant” field provided elsewhere in the application.
For States and U.S. territories with only a single congressional
district enter “001” for the district code. For jurisdictions withno representative, enter “099”. For jurisdictions with anonvoting delegate, enter “098” for the district number.
Example: DC-098, PR-098.

For additional performance site locations, click Next Site to display the fields for Project/Performance
Site Locations 2 through 300.
If you need to add more than 300 locations, enter the information in a separate file. In the Additional
Locations section at the bottom of the form, click Add Attachment, select the file, and then click Open.
A sample Additional Performance Sites format page for greater than eight locations is found under“Additional Format Pages” at: http://grants.nih.gov/grants/funding/424/index.htm.

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4.4 Other Project Information Form

1. Are Human Subjects Involved?
If activities involving human subjects are planned at any time during the proposed project at any
performance site, check yes. Check yes even if the proposed project is exempt from Regulations for theProtection of Human Subjects. If no, skip the rest. This field is required.
Applications proposing human subjects research may be required to submit additional
information, forms, or attachments with the application, in accordance with NIH and PHS
policies covering human subjects research. Refer to Part II, Supplemental Instructions for
Preparing the Human Subjects Section of the Research Plan.

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1.a. If YES to Human Subjects
Is the Project Exempt from Federal Regulations? Yes/No
Yes: If the project is exempt from Federal regulations, check Yes.
No: If the project is not exempt from Federal regulations, check No.
If yes, check appropriate exemption number 1, 2, 3, 4, 5, 6
Select the appropriate exemption number from 1, 2, 3, 4, 5, 6.
If human subject activities are exempt from Federal regulations, provide the exemption numbers
corresponding to one or more of the exemption categories. The six categories of research that qualify for
exemption from coverage by the regulations are defined in the Common Rule for the Protection of Human
Subjects. These regulations can be found at
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.
OHRP guidance states that appropriate use of Exemptions described in 45 CFR 46 should bedetermined by an authority independent from the investigators(http://answers.hhs.gov/ohrp/categories/1564). Institutions often designate their IRB to make thisdetermination. Because NIH does not require IRB approval at the time of application, theexemptions designated often represent the opinion of the PD/PI, and the justification provided forthe exemption by the PD/PI is evaluated during peer review.
Proposed research may include more than one research project; thus the application may include
individual projects that meet the requirements for non-exempt or exempt human subjects
research, or are not defined as human subjects research. Human subjects research should bedesignated as exempt if all of the proposed research meets the criteria for one or more of the six
exemptions.
If no, is the IRB review Pending? Yes/No
If IRB review is pending, check Yes. If IRB review is not pending, check No.
IRB Approval Date
Enter the latest Institutional Review Board (IRB) approval date (if available). Leave blank if Pending.
Applicants should check “Yes” to the question “Is the IRB review Pending?” even if the IRB
review/approval process has not yet begun at the time of submission. Also note that an IRB
Approval Date is not required at the time of submission. This may be requested later in the preaward cycle as a Just-In-Time requirement.
Human Subject Assurance NumberEnter the approved Federal Wide Assurance (FWA), Multiple Project Assurance (MPA), Single Project
Assurance (SPA) Number or Cooperative Project Assurance Number that the applicant has on file with
the Office for Human Research Protections, if available. If the applicant has a FWA number, enter the 8digit number. Do not enter the FWA before the number.
Insert “None” if the applicant organization does not have an approved assurance on file with
OHRP. In this case, the applicant organization, by the signature in the Certification signaturesection on the SF424 (R&R) Cover form, is declaring that it will comply with 45 CFR part 46 andproceed to obtain a human subjects assurances (see http://www.hhs.gov/ohrp). Do not insert thehuman subjects assurance number of any collaborating institution in the space provided.
2. Are Vertebrate Animals Used?
If activities involving vertebrate animals are planned at any time during the proposed project at any
performance site, check yes. If no, skip the rest of block 2. This field is required.

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Note that the generation of custom antibodies constitutes an activity involving vertebrate animals.
If animal involvement is anticipated within the period of award but plans are indefinite, check"Yes" and add a Vertebrate Animals attachment to, provide an explanation and indicate when it isanticipated that animals will be used. If an award is made, prior to the involvement of animals the
grantee must provide all of the information required by adding a Vertebrate Animals attachment
in the Research Plan and verifying of IACUC approval to the awarding component.
2.a. If YES to Vertebrate Animals
Is the IACUC review Pending?
Indicate if an Institutional Animal Care and Use Committee (IACUC) review is pending.
Click Yes if an IACUC review is pending. Click No, if no review is pending.
Check “Yes” even if the IACUC review and approval process has not yet begun.
IACUC Approval Date
Enter the latest IACUC approval date (if available). Leave blank if Pending.
IACUC approval must have been granted within three years to be valid. Note that an IACUC
Approval Date is not required at the time of submission. NIH does not require verification ofreview and approval of the proposed research by the IACUC before peer review of theapplication. However, this information is required under Just-In-Time Policy.
Animal Welfare Assurance NumberEnter the Federally approved assurance number, if available.
Enter “None” if the applicant organization does not have an OLAW-approved Animal Welfare
Assurance. To determine if the applicant organization holds an Animal Welfare Assurance, see
the lists of Domestic and Foreign Assured institutions. Do not enter the Animal Welfare
Assurance number for a Project/Performance Site of a collaborating institution. When an
applicant organization does not have an Animal Welfare Assurance, the Authorized Organization
Representative’s signature on the application constitutes declaration that the applicant
organization will submit an Animal Welfare Assurance when requested by OLAW.
3. Is proprietary/privileged information included in the application?
Patentable ideas, trade secrets, privileged or confidential commercial or financial information, disclosureof which may harm the applicant, should be included in applications only when such information isnecessary to convey an understanding of the proposed project. If the application includes suchinformation, check yes and clearly mark each line or paragraph on the pages containing the
proprietary/privileged information with a legend similar to: "The following contains
proprietary/privileged information that (name of applicant) requests not be released to persons outside theGovernment, except for purposes of review and evaluation. " This field is required.
If a grant is awarded as a result of or in connection with the submission of this application, theGovernment shall have the right to use or disclose the information to the extent authorized bylaw. Although the grantee institution and the PD/PI will be consulted about any such disclosure,the PHS will make the final determination. Any indication by the applicant that the application
contains proprietary or privileged information does not automatically shield the information fromrelease in response to a Freedom of Information Act (FOIA) request should the application resultin an award (see 45 CFR Part 5). If an applicant fails to identify proprietary information at thetime of submission as instructed in the application guide, a significant substantive justification
will be required to withhold the information if requested under FOIA.

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4. Environmental Questions
Most NIH research grants are not expected to individually or cumulatively have a significant
effect on the environment, and NIH has established several categorical exclusions allowing mostapplicants to answer “No” to this question unless a specific FOA indicates that the National
Environmental Policy Act (NEPA) applies. However, if an applicant expects that the proposed
project will have an actual or potential impact on the environment, or if any part of the proposed
research and/or project includes one or more of the following categorical exclusions listed below,
the box marked “Yes” should be checked and an explanation provided.
1.

The potential environmental impacts of the proposed research may be of greater scope orsize than other actions included within a category.

2.

The proposed research threatens to violate a Federal, State, or local law established for theprotection of the environment or for public health and safety.

3.

Potential effects of the proposed research are unique or highly uncertain.

4.

Use of especially hazardous substances or processes is proposed for which adequate andaccepted controls and safeguards are unknown or not available.

5.

The proposed research may overload existing waste treatment plants due to new loads(volume, chemicals, toxicity, additional hazardous wasted, etc.)

6.

The proposed research may have a possible impact on endangered or threatened species.

7.

The proposed research may introduce new sources of hazardous/toxic wastes or require
storage of wastes pending new technology for safe disposal.

8.

The proposed research may introduce new sources of radiation or radioactive materials.

9.

Substantial and reasonable controversy exists about the environmental effects of the
proposed research.

4.a. Does the project have an actual or perceived impact—positive or negative—on theenvironment?
Indicate if this project has an actual or perceived impact on the environment? Click No here if this is not
the case. This field is required.
4.b. If yes, please explain
Explanation of the actual or perceived impact - positive or negative - on the environment.
4.c. If this project has an actual or perceived impact on the environment, has an exemption beenauthorized or an Environmental Assessment (EA) or an Environmental Impact Statement (EIS)
been performed?
Check yes or no. This field is required.
4.d. If yes, please explain
Enter additional details about the EA or EIS.
5. Is the research performance site designated, or eligible to be designated, as a historic place?
Yes/NoIf any research performance site is designated, or eligible to be designated, as a historic place, if Yes,
check the Yes box and then provide an explanation in the box provided in 5.a. Otherwise, check the No
box. This field is required.

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5.a. If yes, please explain:
If you checked the Yes box indicating any performance site is designated, or eligible to be designated, asa historic place, provide the explanation here.
6. Does this project involve activities outside of the United States or partnerships with
International Collaborators?
Indicate whether this project involves activities outside of the United States or partnerships withinternational collaborators. Check yes or no. This field is required.
Applicants to NIH and other PHS agencies must check “Yes” if the applicant organization is aforeign institution or if the project includes a foreign component. For a definition of a foreigncomponent, see “Definitions” section of Supplemental Instructions Part III: Policies, Assurances,
Definitions, and Other Information.
6.a. If yes, identify countries
Enter the countries with which international cooperative activities are involved.
6.b. Optional Explanation
Enter an explanation for involvement with outside entities (optional).
If you have checked “Yes” to 6, applicants to the NIH and other PHS agencies must describe
special resources or characteristics of the research project (e.g., human subjects, animals, disease,equipment, and techniques), whether similar research is being done in the United States andwhether there is a need for additional research in this area. Provide this information in a separate
file, attaching it on the Other Project Information form. In the body of the text, begin the section
with a heading indicating “Foreign Justification.” When saving this file, please name it “Foreign
Justification” as well.
7. Project Summary/Abstract
The Project Summary must contain a summary of the proposed activity suitable for dissemination to the
public. It should be a self-contained description of the project and should contain a statement ofobjectives and methods to be employed. It should be informative to other persons working in the same or
related fields and insofar as possible understandable to a scientifically or technically literate lay reader.
This Summary must not include any proprietary/confidential information. Please click the Add
Attachment button to the right of this field to complete this entry.
The Project Summary is meant to serve as a succinct and accurate description of the proposed
work when separated from the application. State the application’s broad, long-term objectives andspecific aims, making reference to the health relatedness of the project (i.e., relevance to themission of the agency). Describe concisely the research design and methods for achieving thestated goals. This section should be informative to other persons working in the same or related
fields and insofar as possible understandable to a scientifically or technically literate reader.
Avoid describing past accomplishments and the use of the first person. Finally, please make every
effort to be succinct. This section must be no longer than 30 lines of text, and follow the required
font and margin specifications. An abstract which exceeds this allowable length may be flagged
as an error by the agency upon submission. This would require a corrective action before theapplication will be accepted.
As noted above, do not include proprietary, confidential information or trade secrets in thedescription section. If the application is funded, the Project Description will be entered into an
NIH database and made available on the NIH Research Portfolio Online Reporting Tool
(RePORT, available at http://report.nih.gov) and will become public information.

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The attachment must be in PDF format. (See Section 2.6 for additional information on preparing
attachments.)
8. Project Narrative
Provide Project Narrative in accordance with the announcement and/or agency-specific instructions.
Please click the Add Attachment button to the right of this field to complete this entry.
For NIH and other PHS agencies applications, using no more than two or three sentences,
describe the relevance of this research to public health. In this section, be succinct and use plain
language that can be understood by a general, lay audience.
A separate Research Plan form is required for NIH and other PHS agencies applications. Refer to
Section 5.5, Research Plan Form, for separate file uploads and instructions.
9. Bibliography & References Cited
Provide a bibliography of any references cited in the Project Narrative. Each reference must include thenames of all authors (in the same sequence in which they appear in the publication), the article andjournal title, book title, volume number, page numbers, and year of publication. Include only
bibliographic citations. Applicants should be especially careful to follow scholarly practices in providing
citations for source materials relied upon when preparing any section of the application. To attach adocument for Bibliography and References Cited, click Add Attachment.
Unless otherwise noted in an FOA, this section is required for submissions to NIH and other PHS
agencies. This section (formerly “Literature Cited”) should include any references cited in the
PHS 398 Research Plan form (see Section 5.5 for details on completing that form). When citing
articles that fall under the Public Access Policy, were authored or co-authored by the applicant
and arose from NIH support, provide the NIH Manuscript Submission reference number (e.g.,
NIHMS97531) or the PubMed Central (PMC) reference number (e.g., PMCID234567) for eacharticle. If the PMCID is not yet available because the Journal submits articles directly to PMC on
behalf of their authors, indicate “PMC Journal – In Process.” A list of these journals is posted at:
http://publicaccess.nih.gov/submit_process_journals.htm.
Citations that are not covered by the Public Access Policy, but are publicly available in a free,
online format may include URLs or PubMed ID (PMID) numbers along with the full reference(note that copies of publicly available publications are not accepted as appendix material). The
references should be limited to relevant and current literature. While there is not a page
limitation, it is important to be concise and to select only those literature references pertinent to
the proposed research.
10. Facilities & Other Resources
This information is used to assess the capability of the organizational resources available to perform theeffort proposed. Identify the facilities to be used (Laboratory, Animal, Computer, Office, Clinical andOther). If appropriate, indicate their capacities, pertinent capabilities, relative proximity and extent ofavailability to the project. Describe only those resources that are directly applicable to the proposed work.
Provide any information describing the Other Resources available to the project (e.g., machine shop,
electronic shop) and the extent to which they would be available to the project. Please click the Add
Attachment button to the right of this field to complete this entry.
No special form is required but this section must be completed and attached for submissions to
NIH and other PHS agencies unless otherwise noted in an FOA. Describe how the scientificenvironment in which the research will be done contributes to the probability of success (e.g.,
institutional support, physical resources, and intellectual rapport). In describing the scientificenvironment in which the work will be done, discuss ways in which the proposed studies will

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benefit from unique features of the scientific environment or subject populations or will employ
useful collaborative arrangements.
For Early Stage Investigators (ESIs), describe institutional investment in the success of theinvestigator, e.g., resources for classes, travel, training; collegial support such as career
enrichment programs, assistance and guidance in the supervision of trainees involved with the
ESI’s project, and availability of organized peer groups; logistical support such as administrative
management and oversight and best practices training; and financial support such as protected
time for research with salary support. See, http://grants.nih.gov/grants/new_investigators/.
If there are multiple performance sites, describe the resources available at each site.
Describe any special facilities used for working with biohazards or other potentially dangerous
substances. Note: Information about select agents must be described in the Research Plan, Section
11 (Select Agent Research).
11. Equipment
List major items of equipment already available for this project and, if appropriate identify location andpertinent capabilities. Please click the Add Attachment button to the right of this field to complete thisentry.
12. Other Attachments
Attach a file only to provide any other project information not provided above or in accordance with theannouncement and/or agency-specific instruction.

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4.5 Senior/Key Person Profile (Expanded) Form

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This form provides the ability to collect structured data for up to 100 senior/key persons. Data must beentered for the first 100 individuals (PD/PI + 99 others) before the Additional Senior/Key Person Form
Attachments section becomes available. The information for the PD/PI continues to be pre-populated
from the SF424 (R&R) Cover form. See instructions in section 4.2 Cover Form if these fields are empty.
Unless otherwise specified in an agency announcement, senior/key personnel are defined as all
individuals who contribute in a substantive, meaningful way to the scientific development or execution of
the project, whether or not salaries are requested. Consultants should be included if they meet thisdefinition.
Multiple PD/PIs
NIH is now accepting applications reflecting Multiple PD/PIs for all grant activity codes using
the SF424 (R&R) application. When submitting an application involving Multiple PD/PIs, theContact PD/PI must be affiliated in the Commons with the applicant organization and should belisted as the PD/PI in the SF424 R&R Cover Form (see Section 4.2.14). That information
automatically prepopulates the first senior/key person profile record in this form. For the
additional PD/PIs, complete all the requested information. Each PD/PI must be assigned the
PD/PI role, even those at subaward/consortium sites when applicable. (Do not use the “CoPD/PI” or Co-Investigator role.) For more information, please see Section 4.8 Special Instructions
for Preparing Applications with a Subaward/Consortium.
Each PD/PI must also be registered in the eRA Commons and must be assigned the PI Rolein that system (note other roles such as SO or IAR will not give PD/PIs the appropriate
access to the application records). Each PD/PI must include their respective eRA Commons
ID in the Credential field. For more information on NIH Implementation of Multiple PD/PIs,
see: http://grants.nih.gov/grants/multi_pi/index.htm.
When completing the detailed budget form for either the prime organization or a subaward/consortium
organization, the project roles listed in the budget form should be consistent with those used in the
Senior/Key Person Form.
Profile – Program Director/Principal Investigator (PD/PI)
Field Name

Instructions

PrefixPre-populated from the SF 424 (R&R). The prefix (e.g., Mr., Mrs.,
Rev.) for the name of the PD/PI.

First Name

Pre-populated from the SF 424 (R&R). The first (given) name of the
PD/PI. This field is required.

Middle Name

Pre-populated from the SF 424 (R&R). The middle name of the PD/PI.

Last Name

Pre-populated from the SF 424 (R&R). The last (family) name of the
PD/PI. This field is required.

SuffixPre-populated from the SF 424 (R&R). The suffix (e.g., Jr, Sr, PhD) for
the name of the PD/PI.

Position/Title

Pre-populated from the SF 424 (R&R). The title of the PD/PI.

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Field Name

Instructions

Department

Pre-populated from the SF 424 (R&R). The name of primaryorganizational department, service, laboratory, or equivalent level within
the organization of the PD/PI.

Organization Name

Pre-populated from the SF 424 (R&R). The name of organization of the
PD/PI.

Division

Pre-populated from the SF 424 (R&R). The name of primaryorganizational division, office, or major subdivision of the PD/PI.

Street1Pre-populated from the SF 424 (R&R). The first line of the street address
for the PD/PI in the "Street 1" field. This field is required.

Street2Pre-populated from the SF 424 (R&R). The second line of the street
address for the PD/PI in the "Street 2" field. This field is optional.

City

Pre-populated from the SF 424 (R&R). The city for address of PD/PI.
This field is required.

County/Parish

Pre-populated from the SF 424 (R&R). The county/parish for address of
PD/PI.

State

Pre-populated from the SF 424 (R&R). The state where the PD/PI is
located. This field is required if the PD/PI is located in the UnitedStates.

Province

Pre-populated from the SF 424 (R&R). The Province where the PD/PI is
located.
If “Country” is not Canada, this will be blank.

Country

Pre-populated from the SF 424 (R&R). The country for the PD/PI
address. This field is required.

ZIP Code

Pre-populated from the SF 424 (R&R). The postal Code (e.g., ZIP code)of PD/PI. This field is required if the PD/PI is located in the UnitedStates.
A nine-digit Zip code is required.

Phone Number

Pre-populated from the SF 424 (R&R). The daytime phone number for
the PD/PI. This field is required.

Fax Number

Pre-populated from the SF 424 (R&R). The fax number for the PD/PI.

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Field Name

Instructions

E-mailPre-populated from the SF 424 (R&R). The e-mail address for the
PD/PI. This field is required for PD/PI.

Credential, e.g., agency
login

If you are submitting to an agency (e.g., NIH) where you have an
established personal profile, enter the agency ID. If not, leave blank.
For NIH and other PHS agencies, registration in the eRA
Commons for all PD/PIs is required. The assigned Commons
UserName (the unique name used to log into the system) foranyone assigned the PD/PI role must be entered here andmust have the PI role in eRA Commons. This is a required
field for applications submitted to NIH and other PHS
agencies. Applications will not pass agency validation
requirements without this field.

Project Role

Select one. Use "Other" if a category is not listed in the pick list.
Select PD/PI for this person.

Other Project Role Category

Complete if you selected “Other Professional” or “Other” as a projectrole; e.g., Engineer, Chemist.

Degree TypeEnter the highest academic or professional degree or other credentials(e.g., R.N.). This is optional information.

Degree Year

Enter the year the highest degree or other credential was obtained. Thisis optional information.

Attach Biographical Sketch

Provide a biographical sketch for the senior/key person. Recommended
information includes: Education and Training, Research and Professional
Experience, Collaborators and Affiliations (for conflicts of interest),
Publications and Synergistic Activities. Save the information in a single
file and attach here. This is required information.
Biographical sketches should follow the format described below.

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Field Name

Instructions

Attach Current & Pending
Support

Provide a list of all current and pending support for the PD/PI (even if
they receive no salary support from the project(s)) for ongoing projects
and pending applications. Show the total award amount for the entire
award period (including indirect costs) as well as the number of personmonths per year to be devoted to the project by the senior/key person,
regardless of source of support. Concurrent submission of an application
to other organizations for simultaneous consideration will not prejudice
its review.
Unless otherwise required in a specific FOA, do not use this
attachment upload for NIH and other PHS agency submissions.
This information is no longer required at the time of application
submission. This information may be requested later in the preaward cycle. When this occurs, you will be instructed to refer toOther Support in Supplemental Instructions Part III, Policies,
Assurances, Definitions and Other Information.

Profile – Senior/Key Person [n]The remaining senior/key person profiles should be listed in alphabetical order. Whilealphabetical order is preferred, it is not required. However, be aware that these profiles willappear in the application in the order provided by the applicant. Therefore, peer reviewers will
see them in the order presented. Those with a postdoctoral role should be included if they meetthe definition of senior/key personnel. Also use this section to list any Other Significant
Contributors (OSCs). OSCs should be listed after all senior/key persons. OSCs are individuals
who have committed to contribute to the scientific development or execution of the project, but
are not committing any specified measurable effort (in person months) to the project. These
individuals are typically presented at “effort of zero person months” or “as needed” (individuals
with measurable effort cannot be listed as Other Significant Contributors). Consultants should be
included if they meet this definition.
A biosketch, including Research Support information, will be required for these individuals as
this highlights their accomplishments as scientists. Reviewers use these pages to address the“investigator” review criterion. However, if an award is to be made, Other Support information
will not be required or accepted since considerations of overlap do not apply to these individuals.
Should the level of involvement change for an individual listed as an OSC, the individual should
be redesignated as “senior/key personnel.” This change should be made before any compensationis charged to the project.
After providing data for each individual senior/key person, click the Next Person button at thebottom of the form to enter data for the next senior/key person. Continue in this manner until data
has been provided for up to 100 senior/key persons. To ensure proper performance of this form,
after adding 20 additional senior/key persons please save your application, close the Adobe
reader, and reopen it. For applications involving more than 100 senior/key persons, the“Additional Senior/Key Person Profiles” fields will become available once data for the first 100
senior/key persons has been provided.
Field Name

Instructions

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Field Name

Instructions

PrefixEnter the prefix (e.g., Mr., Mrs., Rev.) for the name of the Senior/Key
Person.

First NameEnter the first (given) name of the Senior/Key Person. This field is
required.

Middle NameEnter the middle name of the Senior/Key Person, if applicable.

Last NameEnter the last (family) name of the Senior/Key Person. This field is
required.

SuffixEnter the suffix (e.g., Jr., Sr., Ph.D.) for the name of the Senior/Key
Person.

Position/Title

Enter the title of the Senior/Key Person.

Department

Enter the name of primary organizational department, service, laboratory,or equivalent level within the organization of the Senior/Key Person.

Organization NameEnter the name of organization of the Senior/Key Person.
This is a required field for applications submitted to NIH andother PHS agencies.

DivisionEnter the name of primary organizational division, office, or major
subdivision of the Senior/Key Person.

Street1

Enter first line of the street address for the Senior/Key Person in the"Street 1" field. This field is required.

Street2Enter second line of the street address for the Senior/Key Person in the"Street 2" field. This field is optional.

City

City for address of Senior/Key Person. This field is required

County/Parish

County/ Parish for address of Senior/Key Person.

StateEnter the State where the Senior/Key Person is located. This field is
required if the senior/key person is located in the United States.

ProvinceEnter the Province where the Senior/Key Person is located.
If “Country” is not Canada, please leave blank.

Country

Select the country for the Senior/Key Person address. This field is
required.

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Field Name

Instructions

ZIP CodeEnter the Postal Code (e.g., ZIP code) of Senior/Key Person. This field is
required if the Senior/Key Person is located in the United States.
A nine-digit Zip code is required.

Phone NumberEnter the daytime telephone number for the Senior/Key Person. This fieldis required.

Fax NumberEnter the fax number for the Senior/Key Person.

E-mailEnter the e-mail address for the Senior/Key Person. This field is required
for the Senior/Key Person.

Credential, e.g., agency
login

If you are submitting to an agency (e.g., NIH) where you have an
established personal profile, enter the agency ID. If not, leave blank.
For NIH and other PHS agencies, registration in the eRA
Commons for all PD/PIs is required. The assigned Commons
UserName (the unique name used to log into the system) foranyone assigned the PD/PI role must be entered here andmust have the PI role in eRA Commons. This is a required
field for applications submitted to NIH and other PHS
agencies. Applications will not pass agency validation
requirements without this field.
Note for applications reflecting Multiple PD/PIs, the Commons
UserName must be provided for all individuals assigned the
PD/PI Role on the application.

Project Role

Select one. Use "Other" if a category is not listed in the pick list.
For applications reflecting Multiple PD/PIs, all such individuals
must be assigned the PD/PI role, even those at organizations
other than the applicant organization. The role of “Co-PD/PI” isnot currently used by NIH and other PHS agencies. Assigning an
individual(s) the role of "Co-PD/PI" will not identify theapplication as a Multiple PD/PI application. If applicants wish touse a different role, select “Other” for the Project Role field andthen insert the appropriate role descriptor in the Other Project
Role Category field.
If including individuals classified as “Other Significant
Contributors (OSCs),” use the “Other” category and indicate“Other Significant Contributor” as the role in the “Other Project
Role Category.” OSCs should be listed last after all othersenior/key persons have been listed.

Other Project Role
Category

Complete if you selected “Other Professional” or “Other” as a projectrole; e.g., Engineer, Chemist.

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Field Name

Instructions

Degree TypeEnter the highest academic or professional degree or other credentials(e.g., R.N.). This is optional information.

Degree Year

Enter the year the highest degree or other credential was obtained. This is
optional information.
Applicants should ensure that their degree information is current
in their Commons Profile.

Attach Biographical Sketch

Provide a biographical sketch for the Senior/Key Person. Recommended
information includes: Education and Training, Research and Professional
Experience, Collaborators and Affiliations (for conflicts of interest),
Publications and Synergistic Activities. Save the information in a single
file and attach here. This field is required.
Biographical sketches should follow the format described below.

Attach Current & Pending
Support

Provide a list of all current and pending support for the senior/key person(even if they receive no salary support from the project(s)) for ongoingprojects and pending proposals. Show the total award amount for theentire award period (including indirect costs) as well as the number of
person-months per year to be devoted to the project by the senior/key
person, regardless of source of support. Concurrent submission of a
proposal to other organizations will not prejudice its review.
Unless otherwise required in a specific FOA, do not use this
attachment upload for NIH and other PHS agency submissions.
This information is no longer required at the time of application
submission. This information may be requested later in the preaward cycle. When this occurs, refer to Other Support in
Supplemental Instructions Part III, Policies, Assurances,
Definitions, and Other Information.

Additional Senior/Key Person Profile(s)If more than 99 senior/key person profiles are proposed, enter the information in a separate file and attach
it here.
A sample Additional Senior/Key Person Profiles format page for greater than 100 profiles isfound under “Additional Format Pages” at: http://grants.nih.gov/grants/funding/424/index.htm.
Additional Biographical Sketch(es) (Senior/Key Person)
Provide a biographical sketch for each senior/key person. Recommended information includes: Education
and Training, Research and Professional Experience, Collaborators and Affiliations (for conflicts ofinterest), Publications and Synergistic Activities. Save the information in a single file and attach here.
Biographical Sketches should follow the format described below.

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Additional Current and Pending Support(s)Provide a list of all current and pending support for the PD/PI and each senior/key person (even if theyreceive no salary support from the project(s) for ongoing projects and pending proposals). Show the total
award amount for the entire award period (including indirect costs) as well as the number of person
months per year to be devoted to the project by the senior/key person, regardless of source of support.
Concurrent submission of a proposal to other organizations will not prejudice its review.
Unless otherwise required in a specific FOA, do not use this attachment upload for NIH and other
PHS agency submissions. This information is no longer required at the time of application
submission. This information may be requested later in the pre-award cycle. When this occurs,
refer to Other Support in Supplemental Instructions Part III, Policies, Assurances, Definitions,and Other Information.
Additional NIH and Other PHS Agencies Instructions for a Biographical Sketch
Use the sample format on the Biographical Sketch Format Page to prepare this section for all (modular
and other) grant applications. Include biographical sketches of all senior/key personnel and Other
Significant Contributors. The Biographical Sketch may not exceed four pages per person. This 4-page
limit includes the table at the top of the first page. See the sample of a completed Biographical Sketch. If
the individual is registered in the eRA Commons, include the Commons User Name. This data item isrequired for the PD/PI but is currently optional for all other senior/key persons. In other federal forms thisinformation is referred to as “Credential, e.g., agency login.” For information on the eRA Commons, see
https://commons.era.nih.gov/commons/index.jsp.
Complete the educational block at the top of the format page beginning with baccalaureate or other initialprofessional education, such as nursing, and include postdoctoral training, separately referencing
residency training when applicable. For each entry provide the name and location of the institution; thedegree received (if applicable); the month and year the degree was received, and the field of study. For
residency entries, the field of study section should reflect the area of residency.
Following the educational block, complete sections A, B, C, and D as described below.
A.

Personal Statement. Briefly describe why your experience and qualifications make you particularly
well-suited for your role (e.g., PD/PI, mentor, participating faculty) in the project that is the subjectof the application. Within this section you may, if you choose, briefly describe factors such as familycare responsibilities, illness, disability, and active duty military service that may have affected yourscientific advancement or productivity.

B.

Positions and Honors. List in chronological order previous positions, concluding with your present
position. List any honors. Include present membership on any Federal Government public advisorycommittee.

C.

Selected Peer-reviewed Publication and Patent Citations. NIH encourages applicants to limit thelist of selected peer-reviewed publications, manuscripts in press, and patent citations to no more than
15. Do not include manuscripts submitted or in preparation. The individual may choose to include
selected publications based on recency, importance to the field, and/or relevance to the proposed
research. When citing articles that fall under the Public Access Policy, were authored or co-authoredby the applicant and arose from NIH support, provide the NIH Manuscript Submission reference
number (e.g., NIHMS97531) or the PubMed Central (PMC) reference number (e.g., PMCID234567)
for each article. If the PMCID is not yet available because the Journal submits articles directly to
PMC on behalf of their authors, indicate “PMC Journal – In Process.” A list of these journals isposted at: http://publicaccess.nih.gov/submit_process_journals.htm. Citations that are not covered by
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PubMed ID (PMID) numbers along with the full reference (note that copies of publicly available
publications are not acceptable as appendix material).
D.

Research Support. List both selected ongoing and completed (during the last three years) research
projects (Federal or non-Federal support). Begin with the projects that are most relevant to theresearch proposed in this application. Briefly indicate the overall goals of the projects andresponsibilities of the senior/key person identified on the Biographical Sketch. Do not include
number of person months or direct costs.
Don’t confuse “Research Support” with “Other Support.” Though they sound similar, these parts of
the application are very different. As part of the biosketch section of the application, “Research
Support” highlights your accomplishments, and those of your colleagues, as scientists. This
information will be used by the reviewers in the assessment of each individual’s qualifications for a
specific role in the proposed project, as well as to evaluate the overall qualifications of the researchteam. In contrast, “Other Support” information is required for all applications that are selected toreceive grant awards. NIH staff will request complete and up-to-date “other support” informationfrom you after peer review. This information will be used to check that the proposed research has notalready been Federally-funded.

4.6 Selecting the Appropriate Budget Form
The application forms package associated with most NIH funding opportunities includes two
optional budget forms—(1) R&R Budget Form; and, (2) PHS 398 Modular Budget Form. NIH
applications will include either the R&R Budget Form or the PHS 398 Modular Budget Form, but
not both. (Note AHRQ does not accept modular budgets.)
To determine which budget form to use for NIH applications, consult the modular budget andforeign grantee guidelines below. Additional guidance may also be provided in the specificfunding opportunity announcement.
Modular Budget Guidelines. Modular budgets are applicable to certain research grantapplications requesting $250,000 or less per year for direct costs. Note, consortium/contractual
F&A costs are not factored into the direct cost limit. Consortium F&A costs may be requested inaddition to the $250,000 limit. Modular budgets are simplified; therefore, detailed categoricalinformation is not to be submitted with the application. The modular budget is applicable only toapplications for R01, R03, R15, R21, and R34 and their corresponding cooperative agreement
activity codes.
Instructions for completing a Modular Budget Form can be found in Section 5.4. Instructions forcompleting the R&R Budget Form are provided in the next section.
Foreign Grantee Budget Guidelines. All competing (new, renewal, resubmission, and revision)
grant applications from foreign (non-U.S.) institutions must include only detailed (non-modular)
budgets. For additional information, see NIH Guide Notice NOT-OD-06-096,
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-096.html.
Applications from foreign (non-U.S.) institutions submitted via Grants.gov must follow the
Research & Related Budget Form instructions and must complete and submit the Research &Related Budget forms. Applications from foreign organizations must request budgets in U.S.
dollars.

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4.7 R&R Budget Form
The R&R Budget form includes three separate data entry screens: (1) Sections A and B; (2) Sections C
through E; and (3) Sections F through K. To navigate between the various screens, use the Previous andNext buttons at the top of the form or use the scroll bar on the side of the screen. Complete the R&R
Budget form following the instructions provided. You must complete a separate detailed budget for eachyear of support requested. The form will generate a cumulative budget for the total project period. You
must complete all the required information (i.e., those fields that are highlighted and outlined in red)
before the Next Period button is activated. If no funds are requested for a required field, enter “0.”While the dollar fields allow cents to be entered, all dollar fields should be presented in whole numbers.
Please round to the nearest whole number.
NIH and other PHS agencies use the concept of person months as a metric for determining percent ofeffort. To assist applicants unfamiliar with this concept, resources are available on the web at:
http://grants.nih.gov/grants/policy/person_months_faqs.htm. Frequently asked questions and a conversion
calculator are available.
If funds are being requested for more than one budget period, click the Next Period button at the top of
the third budget screen (Sections F through K) to navigate to screens for the next budget period.
Revision (Supplemental) Application. For a “Revision” (Supplemental) application, show only those
items for which additional funds are requested. If the initial budget period of the supplementation
application is less than 12 months, prorate the personnel costs and other appropriate items of the detailed
budget.

4.7.1 Section A and B

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Enter the DUNS or DUNS+4 number of the applicant organization. For project applicant, this field is prepopulated from the R&R SF424 Cover Page. For subaward applicants, this field is a required enterable
field.
Enter name of Organization
Pre-populated from the R&R SF424. Enter the name of the organization.
Budget Type
Project, Subaward/Consortium: Check the appropriate block. This field is required.
Project: The budget requested for the primary applicant organization.
Subaward/Consortium: The budget requested for subawardee/consortium organization(s). Note, separate
budgets are required only for subawardee/consortium organizations that perform a substantive portion of
the project.
If creating Subaward Budget, use the R&R Subaward Budget Attachment and attach as a separate file on
the R&R Budget Attachment(s) form.
If you are preparing an application that includes a subaward/consortium, see Section 4.8 Special
Instructions for Preparing Applications with a Subaward/Consortium.
Start Date
Pre-populated from the R&R SF424. Enter the requested/proposed start date of each budget period. This
field is required.
End Date
Enter the requested/proposed end date of each budget period. This field is required.
Budget Period
Identify the specific budget period (for example, 1, 2, 3, 4, 5). If submitting through Grants.gov, thesystem will automatically generate a cumulative budget for the total project period. This is a required
field.
(If the Reset Entries button is pressed, please navigate to previous year to enable the submission of theform.)
A. Senior/Key Person
This section should include the names of all senior/key persons at the applicant organization who
are involved on the project in a particular budget year. Include all collaborating investigators, andother individuals meeting the senior/key person definition if they are from the applicant
organization. Details of collaborators at other institutions will be provided in the Subaward
budget for each subaward/consortium organization. Personnel listed as Other Significant
Contributors who are not committing any specific measurable effort to the project should not be
included in the Personnel section of the budget since no associated salary and/or fringe benefits
should be requested for their contribution. Consultants designated as senior/key persons in the
Senior/Key Person Profile Form can be included in Budget Section A only if they are also
employees of the applicant organization. Otherwise, consultant costs should be included in
Consultant Services.
Field Name

Instructions

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Field Name

Instructions

PrefixEnter the prefix (e.g., Mr., Mrs., Rev.) for the name of each Senior/Key
Person.

First NameEnter the first (given) name of each senior/key person. Senior/Key
Person.

Middle NameEnter the middle name of each Senior/Key Person, if applicable.

Last NameEnter the last (family) name of each Senior/Key Person. This field is
required.

SuffixEnter the suffix (e.g., Jr., Sr., PhD) of each Senior/Key Person.

Base Salary ($)

Enter the annual compensation paid by the employer for each Senior/Key
Person. This includes all activities such as research, teaching, patient care,or other. You may choose to leave this column blank.
An applicant organization may choose to leave this blank;
however, PHS staff will request this information prior to award.

Cal. Months

Identify the number of months devoted to the project for each senior/key
person (i.e., calendar, academic, summer).
If effort does not change throughout the year, it is OK to use only
the calendar months column. However, you may use bothacademic and summer months columns if your institutional
business process requires noting each separately even if effort
remains constant. If effort varies between academic and summer
months, leave the calendar months column blank and use only theacademic and summer months columns. Please use either
calendar months OR a combination of academic and summer
months. Some measurable effort is required for every Senior/Key
Person entry.

Acad. Months

Identify the number of months devoted to the project for each senior/key
person (for example, calendar, academic, summer).
If your institution does not use a 9-month academic year, indicate
your institution’s definition of academic year in the budget
justification. Some measurable effort is required for every
Senior/Key Person entry.

Sum. Months

Identify the number of months devoted to the project for each senior/key
person (for example, calendar, academic, summer).
If your institution does not use a 3-month summer period,
indicate your institution’s definition of summer in the budget
justification. Some measurable effort is required for every
Senior/Key Person entry.

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Field Name

Instructions

Requested Salary ($)

Regardless of the number of months being devoted to the project, indicate
only the amount of salary being requested for this budget period for eachsenior/key person. This field is required.
Some PHS grant programs are currently subject to a legislatively
imposed salary limitation. Any adjustment for salary limits will
be made at the time of award; therefore requested salary should
be based on institutional base salary at the time the application is
submitted and not adjusted for any limitation. For guidance on
current salary limitations, see the Salary Cap Summary on the
NIH grants website or contact your office of sponsored programs.
NIH grants also limit the compensation for graduate students.
Compensation includes salary or wages, fringe benefits andtuition remission. While actual institutional-based compensation
should be requested and justified, this may be adjusted at the timeof the award. For more guidance on this policy, see:
http://grants.nih.gov/grants/ guide/notice-files/NOT-OD-02017.html.

Fringe Benefits ($)

Enter applicable fringe benefits, if any, for each senior/key person.

Funds Requested ($)

The requested salary and fringe benefits for each senior/key person. This
field is auto-calculated.

Project Role

Identify the project role of each senior/key person in this section. Thissection could also include such roles as Co-PD/PI, Postdoctoral
Associates, and Other Professionals.
Roles should correspond to the roles included on the Senior/Key
Person Profile (Expanded) Form.

Additional Senior/Key
PersonsIf funds are requested for more than eight senior/key persons, include all
pertinent budget information as identified in this section and attach as afile here. Enter the total funds requested for all additional senior/key
persons in line 9 of Section A. This attachment is required if funds areentered in line 9 of Section A.
Use the same format as the budget form and include all required
information.

Total Funds requested forall persons in the attachedfileEnter the total funds requested for all senior/key persons. This is required
information.

Total Senior/Key Persons

The total funds requested for all senior/key persons.

Special Instructions: Joint University and Department of Veterans Affairs (V.A.)
Appointments
Individuals with joint university and V.A. appointments may request the university’s share ofPart I: Instructions for Preparing and Submitting an Application

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their salary in proportion to the effort devoted to the research project. The individual’s salary withthe university determines the base for computing that request. Signature by the institutional
official on the application certifies that: (1) the individual is applying as part of a joint
appointment specified by a formal Memorandum of Understanding between the university andthe V.A.; and (2) there is no possibility of dual compensation for the same work, or of an actual
or apparent conflict of interest regarding such work. Additional information may be requested by
the awarding components.
B. Other Personnel
Field Name

Instructions

Number of Personnel

For each project role category identify the number of personnel proposed.
In most circumstances, the salaries of administrative or clerical staff at
educational institutions and nonprofit organizations are included as part ofindirect costs. Examples, however, of situations where direct charging ofadministrative or clerical staff salaries may be appropriate may be found
at: http://www.whitehouse.gov/omb/circulars/a021/a21_2004.html#exc.
The circumstances for requiring direct charging of these services must be
clearly described in the budget justification.
For all Postdoctoral Associates and Graduate Students not alreadynamed in Section A. Senior/Key Person, individually list names,
roles (e.g., PostDoc or Graduate Student), associated months, andsalary & fringe benefits requested in the Budget Justification.

Project RoleFor each project role category identify the number of personnel proposed.
List any additional project role(s) in the blank(s) provided, e.g., Engineer,
IT Professionals, etc.
Do not include consultants in this section. Consultants areincluded below in Section F. Other Direct Costs.

Cal. Months

Identify the number of months devoted to the project in the applicable box
for each project role category (i.e., calendar, academic, summer).

Acad. Months

Identify the number of months devoted to the project in the applicablebox for each project role category (i.e., calendar, academic, summer).
If your institution does not use a 9-month academic year, indicate
your institution’s definition of academic year in the budget
justification.

Sum. Months

Identify the number of months devoted to the project in the applicablebox for each project role category (i.e., calendar, academic, summer).
If your institution does not use a 3-month summer period,
indicate your institution’s definition of summer in the budget
justification.

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Field Name

Instructions

Requested Salary ($)

Regardless of the number of months being devoted to the project, indicate
only the amount of salary/wages being requested for each project role.
Some PHS grant programs are currently subject to a legislatively
imposed salary limitation. Any adjustment for salary limits will
be made at the time of award. For guidance on current salary
limitations, see the Salary Cap Summary on the NIH grants
website or contact your office of sponsored programs.
NIH grants also limit the compensation for graduate students.
Compensation includes salary or wages, fringe benefits andtuition remission. While actual institutional-based compensation
should be requested and justified, this may be adjusted at the timeof the award. For more guidance on this policy, see:
http://grants.nih.gov/grants/ guide/notice-files/NOT-OD-02017.html.

Fringe Benefits ($)

Enter applicable fringe benefits, if any, for this project role category.

Funds Requested

This field is auto-calculated.

Total Number of Other
Personnel

This total will auto-calculate. Total Number of Personnel.

Total Other Personnel

Total Funds requested for all other Personnel.

Total Salary, Wages andFringe Benefits (A+B)

Total Funds requested for all Senior/Key persons and all Other Personnel.
This total will auto-calculate.

To navigate to the next page (Sections C through E), click the Next button at the top of the form or use
the scroll bar on the left-hand side of the screen.

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4.7.2 Sections C through E

The information for Organizational DUNS, Budget Type, Name of Organization, and Start and End Dates
is automatically filled in based on the information entered on the first budget screen. To edit thisinformation, return to the initial budget screen (Sections A and B) by clicking the Previous button.
C. Equipment Description
List of items and dollar amount for each item exceeding $5,000.
Field Name

Instructions

Equipment Item

Equipment is defined as an item of property that has an acquisition cost of$5,000 or more (unless the organization has established lower levels) andan expected service life of more than one year. List each item ofequipment separately and justify each in the budget justification section.
Allowable items ordinarily will be limited to research equipment andapparatus not already available for the conduct of the work. Generalpurpose equipment, such as a personal computer, is not eligible forsupport unless primarily or exclusively used in the actual conduct ofscientific research.

Funds Requested

List the estimated cost of each item of equipment including shipping andany maintenance costs and agreements. This is required information.

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Field Name

Instructions

Additional Equipment

If this section cannot accommodate all the equipment proposed, attach afile in the block provided. List each additional item and the funds
requested. For all additional items in the attached file, list the total funds
requested in the following field

Total funds requested forall equipment listed in theattached file

Total funds requested for all equipment listed in the attached file. Dollar
amount for each item should exceed $5000.

Total Equipment

Total Funds requested for all equipment.

D. Travel
Field Name

Instructions

Domestic Travel Costs(Incl. Canada, Mexico, andU.S. Possessions)

Identify the total funds requested for domestic travel. Domestic travelincludes Canada, Mexico, and U.S. possessions. In the budget
justification section, include the purpose, destination, dates of travel (ifknown), and number of individuals for each trip. If the dates of travel are
not known, specify estimated length of trip (e.g., 3 days).

Foreign Travel Costs

Identify the total funds requested for foreign travel. Foreign travelincludes any travel outside of North America and/or U.S. possessions. In
the budget justification section, include the purpose, destination, dates oftravel (if known) and number of individuals for each trip. If the dates oftravel are not known, specify estimated length of trip (e.g., 3 days).

Total Travel Cost

Total Funds requested for all travel.

E. Participant/Trainee Support Costs
Unless specifically stated otherwise in an announcement, NIH and other PHS agencies applicantsshould leave blank Section E. Note: Tuition remission for graduate students should continue to be
included in Section F. Other Direct Costs when applicable.
Field Name

Instructions

Tuition/Fees/Health
Insurance

List total funds requested for Participant/Trainee Tuition / Fees / Healthinsurance.

Stipends

List total funds requested for Participant/Trainee stipends.

TravelList total funds requested for Participant/Trainee travel.

Subsistence

List total funds requested for Participant/Trainee subsistence.

Other

Describe any other participant trainee funds requested. List total funds
requested for any other Participant/Trainee costs described.

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Field Name

Instructions

Number ofParticipants/Trainees

List total number of proposed Participants/Trainees. Value cannot begreater than 999.

Total Participant/Trainee
Support Costs

Total Funds requested for all trainee costs. This field is required if any
data has been entered in section E.

4.7.3 Sections F through K

The information for Organizational DUNS, Budget Type, Name of Organization, and Start and End Dates
is automatically filled in based on the information entered on the first budget screen. To edit thisinformation, return to the initial budget screen (Sections A and B) by clicking the Previous button.

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Special Instructions: Foreign Organizations (Non-domestic [non-U.S. Entities])
Foreign institutions and international organizations may request funds for limited F&A costs (8percent of modified total direct costs less equipment) to support the costs of compliance with
DHHS and NIH requirements including, but not limited to, protection of human subjects, animal
welfare, invention reporting, financial conflict of interest and research misconduct.
Foreign organizations may not include any charge-back of customs and import fees, such as
consular fees, customs surtax, value-added taxes (VAT) and other related charges.
F. Other Direct Costs
Field Name

Instructions

1. Materials and Supplies

List total funds requested for materials and supplies. In the budget
justification, indicate general categories such as glassware, chemicals,
animal costs, including an amount for each category. Categories less than
$1,000 are not required to be itemized.

2. Publication Costs

List the total publication funds requested. The proposal budget may
request funds for the costs of documenting, preparing, publishing, orotherwise making available to others the findings and products of thework conducted under the award. In the budget justification include
supporting information.

3. Consultant Services

List the total costs for all consultant services. In the budget justification,
identify each consultant, the services he/she will perform, total number ofdays, travel costs, and the total estimated costs.
In the budget justification also provide the names andorganizational affiliations of all consultants, other than those
involved in consortium/contractual arrangements. Include
consultant physicians in connection with patient care and persons
who are confirmed to serve on external monitoring boards oradvisory committees to the project. Describe the services to be
performed.

4. ADP/Computer Services

List total funds requested for ADP/computer services. The cost ofcomputer services, including computer-based retrieval of scientific,
technical and education information may be requested. In the budget
justification, include the established computer service rates at the
proposing organization if applicable.

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Field Name

Instructions

5. Subawards/Consortium/
Contractual Costs

List total funds requested for 1) all subaward/consortium organization(s)proposed for the project and 2) any other contractual costs proposed forthe project.
This line item should include both direct and indirect costs for all
subaward/consortium organizations. Contractual costs for support
services, such as the laboratory testing of biological materials,
clinical services, or data processing, are occasionally sufficiently
high to warrant a categorical breakdown of costs. When this is thecase, provide detailed information as part of the budget
justification.
NIH policy provides for exclusion of consortium/contractual
F&A costs when determining if an applicant is in compliancewith a direct cost limitation. Please see the Supplemental
Instructions, Part III, Section 1.1 for additional information
regarding this exclusion Policy

6. Equipment or Facility
Rental/User Fees

List total funds requested for equipment or facility Rental/Use fees. In thebudget justification, identify each rental user fee and justify.

7. Alterations andRenovations

List total funds requested for alterations and renovations. In the budget
justification, itemize by category and justify the costs of alterations andrenovations including repairs, painting, removal or installation ofpartitions, shielding, or air conditioning. Where applicable, provide thesquare footage and costs.
Under certain circumstances the public policy requirements that
apply to construction activities may also apply to A&R activities.
Please refer to the NIH Grants Policy Statement section on“Construction Grants – Public Policy Requirements andObjectives” for more information.
Note, costs for any Alterations and Renovations (A&R) werepreviously unallowable on applications from foreign institutions,international organizations and domestic applications with foreign
subawards. However, an HHS policy change now allows forminor A&R (≤$500,000) on these applications.
When requesting minor A&R costs under this policy, pleaseprovide detailed information on the planned A&R in the budget
justification.

8-10 Other

Add text to describe any “other” direct costs not requested above. Use thebudget justification to further itemize and justify.
List total funds requested for items 8-10 “Other.”
Use lines 8-10 for such costs as patient care and tuition remission.
If requesting patient care costs, request inpatient and outpatient
costs separately using lines 8 and 9.

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Field Name

Instructions

Total Other Direct Costs

Total Funds requested for all other direct costs.

Special Instructions for Patient Care Costs
If inpatient and/or outpatient costs are requested, provide the names of any hospitals and/or
clinics and the amounts requested for each in the budget justification.
State whether each hospital or clinic has a currently effective DHHS-negotiated research patientcare rate agreement and, if not, what basis is used for calculating costs. If an applicant does nothave a DHHS-negotiated rate, the PHS awarding component can approve a provisional rate.
Indicate, in detail, the basis for estimating costs in this category, including the number of patientdays, estimated cost per day, and cost per test or treatment. If both inpatient and outpatient costs
are requested, provide information for each separately. If multiple sites are to be used, provide
detailed information by site.
Include information regarding projected patient accrual for the project/budget periods and relate
this information to the budget request for patient care costs. If patient accrual is anticipated to belower at the start or during the course of the project, plan budget(s) accordingly.
Provide specific information regarding anticipated sources of Other Support for patient care costs,
e.g., third party recovery or pharmaceutical companies. Include any potential or expectedutilization of General Clinical Research Centers.
G. Total Direct Costs (A through F)
Total Funds requested for all direct costs.
H. Indirect Costs
Field Name

Instructions

Indirect Cost Type

Indicate the type of cost e.g.; Salary & Wages, Modified Total Direct
Costs, or Other explain. Also indicate if Off-site. If more than one
rate/base is involved, use separate lines for each. If you do not have acurrent indirect rate(s) approved by a Federal agency, indicate, “None—
will negotiate” and include information for a proposed rate. Use thebudget justification if additional space is needed.

Indirect Cost Rate (%)

Indicate the most recent indirect cost rate(s) (also known as Facilities &Administrative Costs [F&A]) established with the cognizant Federal
office, or in the case of for-profit organizations, the rate(s) establishedwith the appropriate agency. If you have a cognizant/oversight agency andare selected for an award, you must submit your indirect rate proposal tothat office for approval. If you do not have a cognizant/oversight agency,
contact the awarding agency.
If this field does not allow a figure greater than 100% to beentered, use two lines to show the entire calculation. This fieldshould be entered using a rate such as “55.5.”

Indirect Cost Base ($)

Enter the amount of the base for each indirect cost type.

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Field Name

Instructions

Funds Requested

Enter funds requested for each indirect cost type.

Total Indirect Costs

Total Funds requested for indirect costs.

Cognizant Federal Agency

Enter the name of the cognizant Federal Agency, name and phone numberof the individual responsible for negotiating your rate. If no cognizant
agency is known, enter “None.”

I. Total Direct and Indirect Institutional Costs (G + H)
Total Funds requested for direct and indirect costs.
J. FeeGenerally, a fee is not allowed on a grant or cooperative agreement. Do not include a fee in your budget,
unless the program announcement specifically allows the inclusion of a “fee” (e.g., SBIR/STTR). If a fee
is allowable, enter the requested fee.
K. Budget Justification
Use the budget justification to provide the additional information requested in each budget category
identified above and any other information the applicant wishes to submit to support the budget request.
The following budget categories must be justified, where applicable: equipment, travel, participant/trainee
support and other direct cost categories. Only one file may be attached. The attachment is required.
Use this section to list the names, role (e.g., PostDoc or Graduate Student), associated months,
salary and fringe benefits for all Postdoctoral Associates and Graduate Students included in
Budget Section B. Other Personnel.
Include a justification for any significant increases or decreases from the initial year budget.
Justify budgets with more than a standard escalation from the initial to the future year(s) of
support. Also use this section to explain any exclusions applied to the F&A base calculation.
If the application includes a subaward/consortium budget, a separate budget justification is
submitted for that budget. See Section 4.8 Special Instructions for Preparing Applications with a
Subaward/Consortium.
Completing Budget Periods 2-5
If funds are being requested for more than one budget period, you must complete a separate detailed
budget for each year of support requested. To navigate to screens for the next budget period, click the
Next Period button at the top of the 3rd budget screen (Sections F through K). You must complete all therequired information (i.e., those fields that are highlighted and outlined in red) before the Next Period
button is activated. If no funds are requested for a required field, enter “0.” Note the Budget Justificationis also a required item and must be attached before the Next Period button is activated.
Supplemental/Revision Application
For a supplemental/revision application, show only those items for which additional funds arerequested. If the initial budget period of the supplemental/revision application is less than 12
months, prorate the personnel costs and other appropriate items of the detailed budget.
Submitting Budgets With More Than 5 Budget Periods
When authorized or requested by the appropriate NIH IC, applicants may submit applications
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with more than 5 budget periods. In these situations complete the detailed budget for periods 1-5
as usual. However, include the same level of detail for Period 6 in the Budget Justification alongwith an explanation of the situation. Also, be sure to include a cover letter that addresses these
extra budget periods, and include the IC Program Official’s preapproval as part of the CoverLetter PDF.

4.7.4 Cumulative Budget
All values on this form are calculated automatically. They present the summations of the amounts thatyou have entered previously, under Sections A through K, for each of the individual budget periods.
Therefore, no data entry is allowed or required, in order to complete this “Cumulative Budget” section.
If any of the amounts displayed on this form appears to be incorrect, you may correct it by adjusting one
or more of the values that contribute to that total. To make any such adjustments, you will need to revisit
the appropriate budget period form(s), to enter corrected values.

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4.8 Special Instructions for Preparing Applications with a
Subaward/Consortium

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A complete subaward/consortium budget form (including the budget justification section) should becompleted by each consortium grantee organization. Separate budgets are required only for
subawardee/consortium organizations that perform a substantive portion of the project.
Note, a complete subaward/consortium budget form is only required when the prime grantee is submitting
a detailed budget using the R&R Budget Form. Do not use this subaward/consortium budget form forapplications using the PHS 398 Modular Budget Form. Applicants using the Modular Budget Formshould see Section 5.4 for instructions concerning information on consortium budgets.
For any subaward or consortium sites, it is appropriate and expected that someone may be designated as
the consortium lead investigator responsible for ensuring proper conduct of the project or program at thatsite. However, when completing the Project Role for the consortium lead investigator, the project role of“PD/PI” should only be used if the entire application is being submitted under the Multiple PI policy.
Otherwise, this individual should be assigned some other project role in the senior/key personnel sectionof the application. Also, the role of Co-PD/PI is not currently used by NIH and other PHS agencies.
Assigning an individual(s) the role of "Co-PD/PI" will not identify the application as a Multiple PD/PI
application. Although NIH now recognizes the role of “Co-Investigator,” if applicants wish to use the roleof “Consortium PI” or some other similar role, select “Other” for the Project Role field and then insert theappropriate role descriptor in the Other Project Role Category field.
NIH continues to support the policy established in April 2004, (revised in November 2004) regarding
applications that involve consortium/contractual F&A costs (See NOT-OD-05-004). This policy allows
applicants to exclude consortium/contractual F&A costs when determining compliance for any
application where a direct cost limit applies. The use of the SF424 (R&R) application with separately
submitted subaward/consortium budgets allows NIH to take advantage of a system validation for thispolicy. When an application is submitted in response to a program with a direct cost limit, the eRA
system will perform the calculation by taking the total direct costs requested by the prime/parent
organization in their detailed budget, and subtracting all subaward/consortium F&A from each and every
subaward budget attached. When the validation calculation equals or exceeds the respective direct costlimit, the application will receive a warning. There are circumstances, when the system does not havesufficient information to exclude all allowable F&A costs. Applicants should document in their budget
justification, how their budget falls below the direct cost limit.
This form accommodates a set number of separate subaward budgets (30). If you are submitting anapplication with more subaward budgets than the form allows, the remaining budgets should be converted
to PDF and included as part of Section K. Budget Justification of the parent budget. Reminder, the sum of
all subaward budgets; e.g., those attached separately and those provided as part of the budget justification,must be included in Line F.5 Subawards/Consortium/Contractual Costs of the parent budget.
To start the process, the applicant organization should:•

Select the Subaward Budget Attachment Form from the Optional Documents in the Grant
Application Package.

•

Open the form, and click the Click here to extract the R&R Subaward Budget Attachment
button in the middle of the form. A “SAVE” dialog box appears.

•

Save the file locally using the first ten letters of the consortium organization’s name and use“.pdf” as the file extension. (The extracted file is an Adobe PDF file.) Once you have saved thefile there is no need to extract another budget attachment. Doing so may cause you to lose any
data already stored in the saved file.

•E-mail the extracted, saved form to the consortium grantee. Note: consortium grantees must haveinstalled a compatible version of Adobe Reader before they can complete the form. The
consortium grantee should complete all the budget information as instructed in the R&R Budget

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form instructions in Section 4.7. The Budget Type should be set to Subaward/Consortium.
Organizational DUNS and Name of Organization fields must reflect that of thesubaward/consortium grantee.
•

The consortium grantee must complete the budget form and e-mail it back to the applicant
organization.

•

Return to the Subaward Budget Attachment Form and attach the consortium grantee’s budget toone of the blocks provided on the form.

Submitting Subaward Budgets that are not Active for all Periods of the Prime Grant
When submitting subaward budgets that are not active for all periods of the prime grant, fill out thesubaward R&R Budget form and include only the number of periods for which the subaward is active.
The budget period start/end dates reflected in each period should reflect the corresponding prime budget
period start/end dates. This approach is the most workable solution to the limitations in existing forms
that do not allow an “empty” budget period and do not allow submission of a subaward budget with zeroeffort to skip a budget period.
For example, suppose the prime has filled out a budget form with the following periods:•

period 1 Jan 1, 2013 – Dec 31, 2013•

period 2 Jan 1, 2014 – Dec 31, 2014•

period 3 Jan 1, 2015 – Dec 31, 2015•

period 4 Jan 1, 2016 – Dec 31, 2016•

period 5 Jan 1, 2017 – Dec 31, 2017

Now, suppose there is a subaward that performs in support year 1 and does not become active again until
support year 4. The subaward can fill out the first two periods of their budget form as follows:•

period 1 Jan 1, 2013 – Dec 31, 2013 (dates correspond to prime period 1)•

period 2 Jan 1, 2016 – Dec 31, 2016 (dates correspond to prime period 4)

It is not necessary that the budget period numbers between the prime and subaward match; the correlationis reflected in the dates. Do be careful, however, that the dates exactly match what is listed for the period
in the prime budget.
Note this approach may cause a validation warning regarding the NIH $500,000 per year limit on direct
costs, therefore you should document in both the cover letter and the subaward budget justification thatthe subaward is only active for specific periods of the prime. Appropriate NIH staff has access to thecover letter and reviewers have access to the budget justification. This documentation will make the datecorrelation immediately apparent and will help avoid any confusion.

Once all data have been entered use the scroll bar to scroll up. You will be returned to the Grant
Application Package screen. To remove a form from your application, uncheck the box next to the form
name in the Optional document section.

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5.

Completing PHS 398 Form

5.1 Overview
In conjunction with the SF424 (R&R) forms, NIH and other PHS agencies grants applicants should also
complete and submit additional forms titled “PHS 398.” Note the PHS 398 forms include additional datarequired by the agency for a complete application. While these are not identical to the PHS 398
application form pages, the PHS 398 reference is used to distinguish these additional data requirementsfrom the data collected in the SF424 (R&R) forms. A complete application to NIH and other PHS
agencies will include SF424 (R&R) and PHS 398 forms. The PHS 398 forms include:•

PHS 398 Cover Page Supplement (this supplements the data requirements in the R&R Cover
form)

•

PHS 398 Modular Budget Form (use only when a modular budget is submitted instead of adetailed budget)•

PHS 398 Research Plan Form•

Planned Enrollment Report•

PHS 398 Cumulative Inclusion Enrollment ReportComplete each form using the instructions provided below.

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5.2 (Reserved)
5.3 Cover Page Supplement Form

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1. Program Director/Principal Investigator (PD/PI)
Field Name

Instructions

PrefixPre-populated from the SF424 (R&R). The prefix (for example, Mr.,
Mrs., Rev.) for the name of the PD/PI.

First Name

Pre-populated from the SF424 (R&R). The first (given) name of the
PD/PI. This field is required.

Middle Name

Pre-populated from the SF424 (R&R). The middle name of the PD/PI.

Last Name

Pre-populated from the SF424 (R&R). The last (family) name of the
PD/PI. This field is required.

SuffixPre-populated from the SF424 (R&R). The suffix (for example, Jr., Sr.,
PhD) for the name of the PD/PI.

2. Human Subjects
Field Name

Instructions

Clinical Trial?

Check "yes" or "no" to indicate whether the project includes a clinical
trial. See Supplemental Grant Application Instructions, Part III.3. for the
specific definition.

Agency-Defined Phase III
Clinical Trial

Check “Yes” or “No” to indicate whether the project is an NIH-definedPhase III clinical trial.
An NIH-defined Phase III clinical trial is a broadly based prospective
Phase III clinical investigation, usually involving several hundred or morehuman subjects, for the purpose of either evaluating an experimental
intervention in comparison with a standard or control intervention or ofcomparing two or more existing treatments. Often the aim of suchinvestigation is to provide evidence leading to a scientific basis forconsideration of a change in health policy or standard of care. The
definition includes pharmacologic, non-pharmacologic, and behavioral
interventions given for disease prevention, prophylaxis, diagnosis, ortherapy. Community trials and other population-based intervention trials
are also included.

3. *Disclosure Permission Statement
Field Name

Instructions

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Field Name

Instructions

If this application does not
result in an award, is theGovernment permitted todisclose the title of yourproposed project, and thename, address, telephone
number and e-mail addressof the official signing forthe applicant organization,
to organizations that may
be interested in contacting
you for further information(e.g., possible
collaborations,investment)?

Select "yes" or "no" to indicate whether disclosure permission is granted.
This field is required.
Your response will not affect any peer review or funding decisions.

4. Program Income
Field Name

Instructions

Is program income
anticipated during theperiods for which the grantsupport is requested?

If program income is anticipated during the periods for which the grantsupport is requested, check “Yes,” and then complete the section below. If
no program income is anticipated, check “No” and leave the following
section blank.

Budget Period

If program income is anticipated, enter the budget periods in this column.
If the application is funded, the Notice of Grant Award will provide
specific instructions regarding the use of such income.

Anticipated Amount ($)

If program income is anticipated, enter the amount anticipated for eachbudget period listed.

Source(s)If program income is anticipated, enter the source for each budget period
listed.

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5. Human Embryonic Stem Cells
Field Name

Instructions

Does the proposed project
involve human embryonicstem cells?

If the proposed project involves human embryonic stem cells, check Yes
and complete the section below.

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

If a specific line cannot be referenced at the time of application
submission, check this box. Additionally, provide a strong justification for
why an appropriate cell line is not available from the Registry at this time.
The justification should be included as part of the Research Strategy or
Program Plan as appropriate..

Cell Line(s)List in this section the registration number of the specific cell line(s) fromthe NIH Human Embryonic Stem Cell Registry

If the proposed project does not involve human embryonic stem cells,
check No.

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6. Inventions and Patents (For renewal applications only)
Field Name

Instructions

Inventions and Patents

This block need only be completed if submitting an R&R “Renewal”
application or a Resubmission of a Renewal application. If no inventions
were conceived or reduced to practice during the course of work under
this project, check “No.” The remaining parts of the item are then notapplicable. If any inventions were conceived or reduced to practice during
the previous period of support, check “Yes.”
Note: NIH recipient organizations must promptly report inventions to theExtramural Inventions and Technology Resources Branch of the Office of
Policy for Extramural Research Administration, OER, NIH, Bethesda,
MD 20892-2750, (301) 435-1986. Invention reporting complianceaccording to regulations at 37 CFR 401.14 is described at
http://www.iedison.gov. The grantee is encouraged to submit reports
electronically using Interagency Edison (http://www.iedison.gov).

Previously Reported

If the item above is checked "Yes", indicate whether this information has
been reported previously to the PHS or to the applicant organization
official responsible for patent matters.

7. Change of Investigator/Change of Institution Questions
Field Name

Instructions

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Field Name

Instructions

Change of Program
Director/Principal
Investigator

Check here, if this application reflects a change in principal
investigator/program director from that indicated on a previous
application. This is not generally applicable to a "New" application

PrefixIf this application reflects a change in PD/PI, enter the name prefix (forexample, Mr., Mrs., Rev.) of the former PD/PI.

First Name

If this application reflects a change in PD/PI, enter the first name of theformer PD/PI.

Middle Name

If this application reflects a change in PD/PI, enter the middle name of theformer PD/PI.

Last Name

If this application reflects a change in PD/PI, enter the last name of theformer PD/PI.

SuffixIf this application reflects a change in PD/PI, provide the suffix (forexample, Jr., Sr., PhD) of the former PD/PI.

Change of Grantee
Institution

Check here, if this application reflects a change in grantee institution fromthat indicated on a previous application. This is not generally applicable
to a "New" application.

Name of Former Institution

If this application reflects a change in grantee institution, insert the nameof the former institution here.

5.4 Modular Budget Form
Selecting the Appropriate Budget Form
The application forms package associated with most NIH funding opportunities includes two optional
budget forms—(1) R&R Budget Form; and, (2) PHS 398 Modular Budget Form. NIH applications will
include either the R&R Budget Form or the PHS 398 Modular Budget Form but not both. (Note AHRQ
does not accept modular budgets.)
To determine which budget form to use for NIH applications, consult the modular budget guidelines
below. Additional guidance may also be provided in the specific funding opportunity announcement.
Modular Budget Guidelines
Modular budgets are applicable to certain research grant applications from domestic organizations
requesting $250,000 or less per year for direct costs. International organizations and others that do not fallunder this definition should use the detailed budget forms described in Section 4.7. Note,consortium/contractual F&A costs are not factored into the direct cost limit. They may be requested inaddition to the $250,000 limit. Modular budgets are simplified; therefore, detailed categorical information
is not to be submitted with the application.

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For all modular budgets, request total direct costs (in modules of $25,000), reflecting appropriate support
for the project. There will be no future year escalations. A typical modular grant application will request
the same number of modules in each year. Provide an additional narrative budget justification for any
variation in the number of modules requested.
NIH may request (prior to award) additional budget justification in exceptional circumstances. For further
information, see http://grants.nih.gov/grants/funding/modular/modular.htm andhttp://grants.nih.gov/grants/funding/modular/modular_review.htm.
Using the Modular Budget Form
The Modular Budget Form provides budget fields for up to 5 years of support (e.g., budget periods 1 - 5).
If requesting less than 5 years of support, complete only those years requested and leave the others blank.

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5.4.1 Budget Period Form

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NOTE: The form allows for up to five budget periods followed by a cumulative budget for all budget
periods. The fields are the same for all budget periods. The following instructions can be used for each.
Budget Period
Field Name

Instructions

Start Date

Enter the requested/proposed start date of the budget period. Use thefollowing format: MM/DD/YYY.

End Date

Enter the requested/proposed end date of the budget period. Use thefollowing format: MM/DD/YYY.

A. Direct Costs
Field Name

Instructions

Direct Cost less
Consortium F&A

Enter the amount of Direct Costs, less actual consortium F&A costs forthis budget period. This figure must be in $25,000 increments, and it may
not exceed $250,000. Any consortium F&A costs are excluded from thisfigure. This field is required.

Consortium F&A

If this project involves a consortium, enter the actual consortium F&A
costs for this budget period. If this project does not involve a consortium,
leave blank.

Total Direct Costs

This field auto-calculates.

B. Indirect Costs
Field Name

Instructions

Indirect Cost Type

Indicate the type of base (for example, Salary & Wages, Modified Total
Direct Costs, Other [explain]), and indicate if Off-site. If more than one
rate/base is involved, use separate lines for each. If you do not have acurrent indirect rate(s) approved by a Federal agency, indicate, “None—
will negotiate” and include information for a proposed rate. Use thebudget justification if additional space is needed.

Indirect Cost Rate (%)

Indicate the most recent Indirect Cost rate(s) (also known as Facilities &Administrative Costs [F&A]) established with the cognizant Federal
office, or in the case of for-profit organizations, the rate(s) establishedwith the appropriate agency. If you have a cognizant/oversight agency andare selected for an award, you must submit your indirect rate proposal tothat office for approval. If you do not have a cognizant/oversight agency,
contact the awarding agency.

Indirect Cost Base ($)

Enter the amount of the base for each indirect cost type.

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Field Name

Instructions

Funds Requested ($)

Enter funds requested for each indirect cost type.

Cognizant Agency (Agency
Name, POC Name andPhone Number)Enter the name of the cognizant Federal Agency, name, and phone
number of the individual responsible for negotiating your rate. If no
cognizant agency is known, enter “None.”Indirect Cost Rate
Agreement Date

If you have a negotiated rate agreement, enter the agreement date.

Total Indirect Costs

This field auto-calculates.

C. Total Direct and Indirect Costs (A+B) Funds Requested ($)
The total funds requested for direct and indirect costs. This field is required.

Once you have entered all required information for budget period 1, press the Next Period button to enter
information for the subsequent budget period.

5.4.2 Cumulative Budget Information
Cumulative Budget Information
All values for the Cumulative Budget Information are calculated automatically. They equal thesummations of the amounts that you have entered previously for each of the individual budget periods.
Therefore, no data entry is allowed or required, in order to complete this “Cumulative Budget” section.
If any of the amounts displayed on this form appears to be incorrect, you may correct it by adjusting one
or more of the values that contribute to that total. To make any such adjustments, you will need to revisit
the appropriate budget period form(s), to enter corrected values.
Modular Budget Justifications
Field Name

Instructions

Personnel Justification

List all personnel, including names, percent of effort and roles on the
project. No individual salary information should be provided. Since themodules should be a reasonable estimate of costs allowable, allocable,
and appropriate for the proposed project, applicants must use the current
legislatively imposed salary limitation when estimating the number ofmodules. For guidance on current salary limitations contact your office ofsponsored programs.
NIH grants also limit the compensation for graduate students.
Compensation includes salary or wages, fringe benefits and tuition
remission. This limit should also be used when estimating the number ofmodules. See: http://grants1.nih.gov/grants/guide/notice-files/NOT-OD02-017.html
Save the information in a single file and click the add attachment button

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Field Name

Instructions
to complete this entry.

Consortium Justification

Provide an estimate of total costs (direct plus Facilities andAdministrative) for each year, rounded to the nearest $1,000. List theindividuals/ organizations with whom consortium or contractual
arrangements have been made. List all personnel, including percent ofeffort and roles on the project. No individual salary information should be
provided. Indicate whether the collaborating institution is foreign ordomestic. While only the direct cost for a consortium/contractual
arrangement is factored into eligibility for using the modular budget
format, the total consortium/contractual costs must be included in theoverall requested modular direct cost amount.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

Additional Narrative
Justification

If the requested budget requires any additional justification; e.g, variationsin the number of modules requested, save the information in a single fileand click the add attachment button to complete this entry.

Once all data have been entered use the scroll bar to scroll up. You will be returned to the Grant
Application Package screen. To remove a form from your application, uncheck the box next to the form
name in the Optional document section.

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5.5 PHS 398 Research Plan Form

The Research Plan should include sufficient information needed for evaluation of the project, independentof any other document (e.g., previous application). Be specific and informative, and avoid redundancies.
Research Plan Attachments (See also Section 2.3.2 Creating PDFs for Text Attachments)
Text attachments should be generated using word processing software and then converted to PDF using
PDF generating software. Avoid scanning text attachments to convert to PDF since that causes problems
for the agency handling the application. In addition, be sure to save files with descriptive file names.
Do not include any information in a header or footer of the attachments. A header will be systemgenerated that references the name of the PD/PI. Page numbers for the footer will be system-generated in
the complete application, with all pages sequentially numbered.

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Since a number of reviewers will be reviewing applications as an electronic document and not a paper
version, applicants are strongly encouraged to use only a standard, single-column format for the text.
Avoid using a two-column format since it can cause difficulties when reviewing the document
electronically.
Full-sized glossy photographs of material such as electron micrographs or gels must only be included
within the page limits of the Research Strategy. The maximum size of images to be included should beapproximately 1200 x 1500 pixels using 256 colors. Figures must be readable as printed on an 8.5 x 11
inch page at normal (100%) scale.
Investigators must use image compression such as JPEG or PNG. Do not include figures or photographs
as separate attachments either in the Appendix or elsewhere in the application.
Separate Attachments
Separate attachments have been designed for the Research Plan sections to maximize automatic
validations conducted by the eRA system. When the application is received by the agency, all of the
Research Plan sections will be concatenated in the appropriate order so that reviewers and agency staff
will see a single cohesive Research Plan.
When attaching a PDF document to the actual forms, please note you are attaching an actual document,
not just pointing to the location of an externally stored document. Therefore, if you revise the document
after it has been attached, you must delete the previous attachment and then reattach the revised
document to the application form. Use the View Attachment button to determine if the correct version
has been attached.
Page Limits
Applicants must follow the page limits described in table 2.6.1 unless the FOA specifies otherwise.
All tables, graphs, figures, diagrams, and charts must be included within the Research Strategy page limit.
If PAs or RFAs contain specific page limits, those instructions always supersede these instructions.
All applications and proposals for NIH funding must be self-contained within specified page limits.
Agency validations will include many checks for page limits. Note that while these computer validations
will help minimize incomplete and/or non-compliant applications, they may not address all page limit
requirements for a specific FOA and do not replace the validations conducted by NIH staff. Applications
found not to comply with the requirements may be delayed in the review process. Unless otherwise
specified in an NIH solicitation, internet website addresses (URLs) may not be used to provide
information necessary to the review because reviewers are not obligated to view the internet sites.
Moreover, reviewers are cautioned that they should not directly access an website (except to review
publications cited in the Biographical Sketch or Progress Report publication list) as it could compromise
their anonymity.
Applicants are prohibited from using the Appendix to circumvent page limitations in any section of theapplication for which a page limit applies. For additional information regarding Appendix material andpage limits, please refer to the NIH Guide Notice NOT-OD-11-080,
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-080.html.
Notice of Proprietary Information
Applicants are discouraged from submitting information considered proprietary unless it is deemed
essential for proper evaluation of the application. However, when the application contains informationthat constitutes trade secrets, or information that is commercial or financial, or information that isconfidential or privileged, make sure you have checked “Yes” for the proprietary/privileged informationquestion in the Other Project Information form.

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When information in the application constitutes trade secrets or information that is commercial or
financial, or information that is confidential or privileged, it is furnished to the Government in confidencewith the understanding that the information shall be used or disclosed only for evaluation of thisapplication. However, if a grant is awarded as a result of or in connection with the submission of thisapplication, the Government shall have the right to use or disclose the information to the extent
authorized by law. This restriction does not limit the Government’s right to use the information if it isobtained without restriction from another source.
Although the grantee institution and the PD/PI will be consulted about any such release, the PHS will
make the final determination. Any indication by the applicant that the application contains proprietary or
privileged information does not automatically shield the information from release in response to a
Freedom of Information Act (FOIA) request should the application result in an award (see 45 CFR Part5). If an applicant fails to identify proprietary information at the time of submission as instructed in theapplication guide, a significant substantive justification will be required to withhold the information if
requested under FOIA.
Begin each text section of the Research Plan with a section header (e.g., Introduction, SpecificAims, Research Strategy, etc).
Field Name

Instructions

1. Introduction to
Application (forResubmission or Revision
only)

Use only if Type of Application is Resubmission or Revision. See specificinstructions in Part I Section 2.7, Resubmission Applications and Part I
Section 2.8, Revision Applications on the content of the Introduction.
First time (new) applications should not include an Introduction.
The Introduction is a required attachment for Resubmissions andRevisions. Follow the page limits for the Research Strategy in the table ofpage limits (Table 2.6-1), unless specified otherwise in the FOA.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

2. Specific Aims

State concisely the goals of the proposed research and summarize theexpected outcome(s), including the impact that the results of the proposed
research will exert on the research field(s) involved.
List succinctly the specific objectives of the research proposed, e.g., totest a stated hypothesis, create a novel design, solve a specific problem,
challenge an existing paradigm or clinical practice, address a criticalbarrier to progress in the field, or develop new technology.
The Specific Aims attachment is required unless otherwise specified in
the FOA. Follow the page limits for the Research Strategy in the table ofpage limits (Table 2.6-1), unless specified otherwise in the FOA.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

3. Research Strategy

Organize the Research Strategy in the specified order and using the
instructions provided below. Start each section with the appropriate
section heading – Significance, Innovation, Approach. Cite publishedPart I: Instructions for Preparing and Submitting an Application

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experimental details in the Research Strategy section and provide the fullreference in the Bibliography and References Cited section (Part I Section
4.4.9).
Follow the page limits for the Research Strategy in the table of page limits(Table 2.6-1), unless specified otherwise in the FOA. Note that the page
limit for this attachment will be validated as a single file.
(a) Significance•••

Explain the importance of the problem or critical barrier toprogress in the field that the proposed project addresses.
Explain how the proposed project will improve scientificknowledge, technical capability, and/or clinical practice in
one or more broad fields.
Describe how the concepts, methods, technologies,
treatments, services, or preventative interventions that drive
this field will be changed if the proposed aims are achieved.

(b) Innovation•••

Explain how the application challenges and seeks to shift
current research or clinical practice paradigms.
Describe any novel theoretical concepts, approaches or
methodologies, instrumentation or interventions to be
developed or used, and any advantage over existing
methodologies, instrumentation, or interventions.
Explain any refinements, improvements, or new applicationsof theoretical concepts, approaches or methodologies,
instrumentation, or interventions.

(c) Approach
•

•
•

•

•

Describe the overall strategy, methodology, and analyses tobe used to accomplish the specific aims of the project. Unlessaddressed separately the Resource Sharing Plan, attachment
include how the data will be collected, analyzed, andinterpreted as well as any resource sharing plans as
appropriate.
Discuss potential problems, alternative strategies, andbenchmarks for success anticipated to achieve the aims.
If the project is in the early stages of development, describe
any strategy to establish feasibility, and address the
management of any high risk aspects of the proposed work.
Point out any procedures, situations, or materials that may behazardous to personnel and precautions to be exercised. A full
discussion on the use of select agents should appear in the
Select Agent Research attachment, below.
If research on Human Embryonic Stem Cells (hESCs) is
proposed but an approved cell line from the NIH hESC

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Registry cannot be identified, provide a strong justification
for why an appropriate cell line cannot be chosen from theRegistry at this time.
If an applicant has multiple Specific Aims, then the applicant may address
Significance, Innovation and Approach for each Specific Aim
individually, or may address Significance, Innovation and Approach for
all of the Specific Aims collectively.
As applicable, also include the following information as part of the
Research Strategy, keeping within the three sections listed above:
Significance, Innovation, and Approach.
Preliminary Studies for New Applications: For new applications,
include information on Preliminary Studies. Discuss the PD/PI’s
preliminary studies, data, and or experience pertinent to this application.
Except for Exploratory/Developmental Grants (R21/R33), Small Research
Grants (R03), and Academic Research Enhancement Award (AREA)
Grants (R15), preliminary data can be an essential part of a research grantapplication and help to establish the likelihood of success of the proposed
project. Early Stage Investigators should include preliminary data
(however, for R01 applications, reviewers will be instructed to place lessemphasis on the preliminary data in application from Early Stage
Investigators than on the preliminary data in applications from moreestablished investigators).
Progress Report for Renewal and Revision Applications. For
renewal/revision applications, provide a Progress Report. Provide thebeginning and ending dates for the period covered since the lastcompetitive review. Summarize the specific aims of the previous project
period and the importance of the findings, and emphasize the progress
made toward their achievement. Explain any significant changes to thespecific aims and any new directions including changes to the specificaims and any new directions including changes resulting from significant
budget reductions. A list of publications, patents, and other printed
materials should be included in the Progress Report Publication List
attachment; do not include that information here.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

4. Progress Report
Publication List (Renewal
Applications Only)

List the titles and complete references to all appropriate publications,
manuscripts accepted for publication, patents, and other printed materials
that have resulted from the project since it was last reviewed
competitively. When citing articles that fall under the Public AccessPolicy, were authored or co-authored by the applicant and arose from NIH
support, provide the NIH Manuscript Submission reference number (e.g.,
NIHMS97531) or the PubMed Central (PMC) reference number (e.g.,
PMCID234567) for each article. If the PMCID is not yet available
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authors, indicate “PMC Journal – In Process.” A list of these journals isposted at: http://publicaccess.nih.gov/submit_process_journals.htm.
Citations that are not covered by the Public Access Policy, but are
publicly available in a free, online format may include URLs or PubMed
ID (PMID) numbers along with the full reference (note that copies ofthese publications are not accepted as appendix material, see Part I
Section 5.5.15 for more information).

Human Subjects Sections
Field Name

Instructions

5. Protection of Human
Subjects

Refer to Part II, Supplemental Instructions for Preparing the Human
Subjects Section of the Research Plan.
Complete this section if you answered “yes” to the question “are humansubjects involved?” on the R&R Other Project Information Form. If you
answered “no” to the question but your proposed research involves humanspecimens and/or data from subjects you must provide a justification inthis section or your claim that no human subjects are involved. Follow the
instructions provided in the Application Guide and the FOA regarding theProtection of Human Subject attachment.
Do not use the protection of human subjects section to circumvent thepage limits of the Research Strategy.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

6. Inclusion of Women andMinorities

Refer to Part II, Supplemental Instructions for Preparing the Human
Subjects Section of the Research Plan. Complete this section if you
answered “yes” to the question “are human subjects involved?” on the
R&R Other Project Information Form and the research does not fall under
Exemption 4.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

7. Inclusion of Children

Refer to Supplemental Instructions for Preparing the Human Subjects
Section of the Research Plan, Sections 4.4 and 5.7 Complete this section
if you answered “yes” to the question “are human subjects involved?” on
the R&R Other Project Information Form and the research does not fallunder Exemption 4.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

Other Research Plan Sections

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8. Vertebrate
Animals

Complete this section if you answered “yes” to the question “are Vertebrate
Animals Used?” on the R&R Other Project Information Form.
If Vertebrate Animals are involved in the project, address each of the five points
below. This section should be a concise, complete description of the animals
and proposed procedures. While additional details may be included in the
Research Strategy, the responses to the five required points below must be
cohesive and include sufficient detail to allow evaluation by peer reviewers andNIH staff. If all or part of the proposed research involving vertebrate animals
will take place at alternate sites (such as project/performance or collaboratingsite(s)), identify those sites and describe the activities at those locations.
Although no specific page limitation applies to this section of the application,
be succinct. Failure to address the following five points will result in theapplication being designated as incomplete and will be grounds for the PHS todefer the application from the peer review round. Alternatively, theapplication’s impact/priority score may be negatively affected.
If the involvement of animals is indefinite, provide an explanation and indicate
when it is anticipated that animals will be used. If an award is made, prior to theinvolvement of animals the grantee must submit to the NIH awarding officedetailed information as required in points 1-5 below and verification of IACUC
approval. If the grantee does not have an Animal Welfare Assurance, then an
applicable Animal Welfare Assurance will be required (see Part III Section 2.2
Vertebrate Animals for more information).
The five points are as follows:1.

Provide a detailed description of the proposed use of the animals in thework outlined in the Research Strategy section. Identify the species,
strains, ages, sex, and numbers of animals to be used in the proposed work.

2.

Justify the use of animals, the choice of species, and the numbers to be
used. If animals are in short supply, costly, or to be used in large numbers,
provide an additional rationale for their selection and numbers.

3.

Provide information on the veterinary care of the animals involved.

4.

Describe the procedures for ensuring that discomfort, distress, pain, andinjury will be limited to that which is unavoidable in the conduct ofscientifically sound research. Describe the use of analgesic, anesthetic, andtranquilizing drugs and/or comfortable restraining devices, whereappropriate, to minimize discomfort, distress, pain, and injury.

5.

Describe any method of euthanasia to be used and the reasons for its
selection. State whether this method is consistent with therecommendations of the American Veterinary Medical Association(AVMA) Guidelines on Euthanasia. If not, include a scientific justification
for not following the recommendations.

For additional information, see
http://grants.nih.gov/grants/olaw/VASchecklist.pdf.
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Research Strategy.
Save this information in a single file in a location you remember. Click Add
Attachment, browse to where you saved the file, select the file, and then clickOpen.

9. Select Agent
Research

Select agents are hazardous biological agents and toxins that have been
identified by DHHS or USDA as having the potential to pose a severe threat to
public health and safety, to animal and plant health, or to animal and plant
products. CDC and the Animal APHIS Select Agent Programs jointly maintaina list of these agents. See http://www.selectagents.gov/.
If the activities proposed in the application involve only the use of a strain(s) ofselect agents which has been excluded from the list of select agents and toxins
as per 42 CFR 73.3, the select agent requirements do not apply. Use this section
to identify the strain(s) of the select agent that will be used and note that it has
been excluded from this list. The list of exclusions is available at
http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20Exclusio
ns.html.
If the strain(s) is not currently excluded from the list of select agents and toxins
but you have applied or intend to apply to DHHS for an exclusion from the list,
use this section to indicate the status of your request or your intent to apply foran exclusion and provide a brief justification for the exclusion.
If any of the activities proposed in your application involve the use of selectagents at any time during the proposed project period, either at the applicant
organization or at any other performance site, address the following three points
for each site at which select agent research will take place. Although no specificpage limitation applies to this section, be succinct.
1.

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

2.

Provide the registration status of all entities* where select agent(s) will beused.
•

If the performance site(s) is a foreign institution, provide thename(s) of the country or countries where select agent research will
be performed.

*An “entity” is defined in 42 CFR 73.1 as “any government agency(Federal, State, or local), academic institution, corporation, company,
partnership, society, association, firm, sole proprietorship, or other legal
entity.”3.

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

Describe the procedures that will be used to monitor possession, use
and transfer of the select agent(s).
Describe plans for appropriate biosafety, biocontainment, andsecurity of the select agent(s).
Describe the biocontainment resources available at all performancesites.

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If you are responding to a specific funding opportunity announcement (e.g., PA
or RFA), address any requirements specified by the FOA.
Reviewers will assess the information provided in this Section, and anyquestions associated with select agent research will need to be addressed prior
to award.
Save this file in a location you remember. Click Add Attachment, browse towhere you saved the file, select the file, and then click Open.

10. Multiple PD/PI
Leadership Plan

For applications designating multiple PD/PIs, a leadership plan must be
included. For applications designating multiple PD/PIs, all such individuals
must be assigned the PD/PI role on the Senior/Key Profile form, even those atorganizations other than the applicant organization. A rationale for choosing a
multiple PD/PI approach should be described. The governance andorganizational structure of the leadership team and the research project should
be described, including communication plans, process for making decisions on
scientific direction, and procedures for resolving conflicts. The roles andadministrative, technical, and scientific responsibilities for the project orprogram should be delineated for the PD/PIs and other collaborators. Do not
submit a leadership plan if you are not submitting a Multiple PD/PI application.
If budget allocation is planned, the distribution of resources to specific parts ofthe project or the individual PD/PIs should be delineated in the Leadership Plan.
In the event of an award, the requested allocations may be reflected in afootnote on the Notice of Grant Award.
Save this file in a location you remember. Click Add Attachment, browse towhere you saved the file, select the file, and then click Open.

11.
Consortium/Contract
ual Arrangements

Explain the programmatic, fiscal, and administrative arrangements to be madebetween the applicant organization and the consortium organization(s). If
consortium/contractual activities represent a significant portion of the overall
project, explain why the applicant organization, rather than the ultimate
performer of the activities, should be the grantee. The signature of the
Authorized Organization Representative on the SF424 (R&R) cover form
signifies that the applicant and all proposed consortium participants understandand agree to the following statement:
The appropriate programmatic and administrative personnel of eachorganization involved in this grant application are aware of theagency’s consortium agreement policy and are prepared to establish thenecessary inter-organizational agreement(s) consistent with that policy.
Save this information in a single file in a location you remember. Click Add
Attachment, browse to where you saved the file, select the file, and then clickOpen.

12. Letters of Support(e.g., Consultants)

Provide all appropriate letters of support, including any letters necessary todemonstrate the support of consortium participants and collaborators such as
Senior/Key Personnel and Other Significant Contributors included in the grantapplication. Letters are not required for personnel (such as research assistants)

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not contributing in a substantive, measurable way to the scientific development
or execution of the project. Letters should stipulate expectations for coauthorship, and whether cell lines, samples or other resources promised in theletter are freely available to other investigators in the scientific community or
will be provided to the particular investigators only. For consultants, lettersshould include rate/charge for consulting services and level of effort/number ofhours per year anticipated. In addition, letters ensuring access to core facilities
and resources should stipulate whether access will be provided as a fee-forservice. Do not place these letters in the Appendix. Consultant biographicalsketches should be in the Biographical Sketch section.
Save this information in a single file in a location you remember. Click Add
Attachment, browse to where you saved the file, select the file, and then clickOpen.

13. Resource Sharing
Plan(s)

NIH considers the sharing of unique research resources developed through NIHsponsored research an important means to enhance the value and further theadvancement of the research. When resources have been developed with NIH
funds and the associated research findings published or provided to NIH, it isimportant that they be made readily available for research purposes to qualified
individuals within the scientific community. See Supplemental Instructions Part
III, 1.5 Sharing Research Resources.
1. Data Sharing Plan: Investigators seeking $500,000 or more in direct costs(exclusive of consortium F&A) in any year are expected to include a brief 1paragraph description of how final research data will be shared, or explain why
data-sharing is not possible. Specific Funding Opportunity Announcements may
require that all applications include this information regardless of the dollar
level. Applicants are encouraged to read the specific opportunity carefully anddiscuss their data-sharing plan with their program contact at the time theynegotiate an agreement with the Institute/Center (IC) staff to accept assignmentof their application. See Data-Sharing Policy or
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
2. Sharing Model Organisms: Regardless of the amount requested, allapplications where the development of model organisms is anticipated are
expected to include a description of a specific plan for sharing and distributing
unique model organisms or state why such sharing is restricted or not possible.
See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
3. Genome Wide Association Studies (GWAS): Applicants seeking funding for a
genome-wide association study are expected to provide a plan for submission of
GWAS data to the NIH-designated GWAS data repository, or an appropriate
explanation why submission to the repository is not possible. GWAS is defined
as any study of genetic variation across the entire genome that is designed to
identify genetic associations with observable traits (such as blood pressure or
weight) or the presence or absence of a disease or condition. For further
information see Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088,
and http://gwas.nih.gov/.

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Save this information in a single file in a location you remember. Click Add
Attachment, browse to where you saved the file, select the file, and then clickOpen.

15. Appendix

Only one copy of appendix material is necessary. Use the Add Attachments
button to the right of this field to complete this entry.
A maximum of 10 PDF attachments is allowed in the Appendix. If more than 10
appendix attachments are needed, combine the remaining information into
attachment #10. Note that this is the total number of appendix items, not the
total number of publications. When allowed there is a limit of 3 publications
that are not publicly available (see below for further details and check the FOA
for any specific instructions), though not all grant activity codes allow
publications to be included in the appendix.
Do not use the appendix to circumvent the page limits of the Research Strategy
or any other section of the application for which a page limit applies. For
additional information regarding Appendix material and page limits, pleaserefer to the NIH Guide Notice NOT-OD-11-080,
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-080.html.
Appendix material may not appear in the assembled application in the orderattached, so it is important to use filenames for attachments that are descriptiveof the content. A summary sheet listing all of the items included in the appendix
is also encouraged but not required. When including a summary sheet, it should
be included in the first appendix attachment. Applications that do not follow theappendix requirements may be delayed in the review process.
New, resubmission, renewal, and revision applications may include thefollowing materials in the Appendix (note, however, that some FOAs do not
permit publications):•

Publications – No longer allowed as appendix materials except
in the circumstances noted below. Applicants may submit up to 3of the following types of publications:oManuscripts and/or abstracts accepted for publication but
not yet published: The entire article should be submitted as a
PDF attachment.

oManuscripts and/or abstracts published, but a free, online,
publicly available journal link is not available: The entire
article should be submitted as a PDF attachment.

oPatents directly relevant to the project: The entire document
should be submitted as a PDF attachment.

(Do not include unpublished theses, or abstracts/manuscripts submitted(but not yet accepted) for publication.)•

Surveys, questionnaires, and other data collection instruments;
clinical protocols and informed consent documents may besubmitted in the Appendix as necessary.

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For materials that cannot be submitted electronically or materials
that cannot be converted to PDF format (e.g., medical devices,
prototypes, DVDs, CDs), applicants should contact the Scientific
Review Officer for instructions following notification of
assignment of the application to a SRG. Applicants are encouraged
to be as concise as possible and submit only information essential
for the review of the application.

Items that must not be included in the appendix:•

Photographs or color images of gels, micrographs, etc., are nolonger accepted as Appendix material. These images must be
included in the Research Strategy PDF. However, images
embedded in publications are allowed.

•

Publications that are publicly accessible. For such publications, the
URL or PMC submission identification numbers along with the fullreference should be included as appropriate in the Bibliography andReferences cited section, the Progress Report Publication List
section, and/or the Biographical Sketch section.

Once all data have been entered use the scroll bar to scroll up. You will be returned to the Grant
Application Package screen. To remove a form from your application, uncheck the box next to the form
name in the Optional document section.

5.6 (Reserved)
5.7 (Reserved)
5.8 Planned Enrollment Report and Cumulative Inclusion
Enrollment Report
NOTE: These report formats should NOT be used for collecting data from study participants. To
ensure proper performance, please save frequently.

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Study Title

Enter a unique title that describes the study that the participants will be
involved in. If there is more than one study, provide a separate Study Title
for each. Follow the instructions provided in the Application Guide andthe FOA regarding the Inclusion of Women and Minorities. Maximum
250 characters. This is a required field.

Domestic/Foreign

Select whether the participants described in the planned enrollment report
are domestic or foreign. At a minimum, domestic and foreign participants
must be reported separately even if for the same study. This is a required
field.

Comments

Enter information you wish to provide about this planned enrollment
report. This includes but is not limited to addressing information about
distinctive subpopulations if relevant to the scientific hypotheses being
studied and/or a study that will have a delayed onset. Maximum 500
characters.

American Indian/Alaska
NativeEnter the expected number of females and males (in the respective fields)
who are American Indian/Alaska Native and Not Hispanic or Latino, and;enter the expected number of females and males (in the respective fields)
who are American Indian/Alaska Native and Hispanic or Latino. These
are required fields.

AsianEnter the expected number of females and males (in the respective fields)
who are Asian and Not Hispanic or Latino, and; enter the expected
number of females and males (in the respective fields) who are Asian and
Hispanic or Latino. These are required fields.

Native Hawaiian or Other
Pacific IslanderEnter the expected number of females and males (in the respective fields)
who are Native Hawaiian or Other Pacific Islander and Not Hispanic or
Latino, and; enter the expected number of females and males (in therespective fields) who are Native Hawaiian or Other Pacific Islander and
Hispanic or Latino. These are required fields.

Black or African American

Enter the expected number of females and males (in the respective fields)
who are Black or African American and Not Hispanic or Latino, and;Enter the expected number of females and males (in the respective fields)
who are Black or African American and Hispanic or Latino. These are
required fields.

White

Enter the expected number of females and males (in the respective fields)
who are White and Not Hispanic or Latino, and; enter the expected
number of females and males (in the respective fields) who are White andHispanic or Latino. These are required fields.

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More than One RaceEnter the expected number of females and males (in the respective fields)
who identify with more than one racial category and are Not Hispanic or
Latino, and; enter the expected number of females and males (in therespective fields) who identify with more than one racial category and are
Hispanic or Latino. These are required fields.

Total

The total fields at the bottom are auto-calculated to total all racial
categories for females and males who are Not Hispanic or Latino and all
racial categories for females and males who are Hispanic or Latino. The
total fields at the right are auto-calculated to total all males and females ofboth Not Hispanic or Latino and Hispanic or Latino ethnicity in each
racial category.

5.8.2 Cumulative Inclusion Enrollment Report

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Study Title

Enter a unique title that describes the study that the participants will be
involved in. The title should be the same as submitted on the originalPlanned Enrollment form for this study. Follow the instructions provided
in the Application Guide and the FOA regarding the Inclusion of Womenand Minorities. Maximum 250 characters. This is a required field.

Comments

Enter information you wish to provide about this Cumulative Inclusion
Enrollment Report. This includes but is not limited to information if
distinctive subpopulations are relevant to the scientific hypotheses being
studied. Maximum 500 characters.

American Indian/Alaska
NativeEnter the number of females, males, and individuals of unknown/not
reported sex/gender (in the respective fields) who are American
Indian/Alaska Native and Not Hispanic or Latino, and; enter the numberof females, males, and individuals of unknown/not reported sex/gender (inthe respective fields) who are American Indian/Alaska Native andHispanic or Latino; and enter the number of females, males, andindividuals of unknown/not reported sex/gender (in the respective fields)
who are American Indian/Alaska Native and of unknown/not reported
ethnicity. These are required fields.

AsianEnter the number of females, males, and individuals of unknown/not
reported sex/gender (in the respective fields) who are Asian and Not
Hispanic or Latino, and; enter the number of females, males, andindividuals of unknown/not reported sex/gender (in the respective fields)
who are Asian and Hispanic or Latino; and enter the number of females,
males, and individuals of unknown/not reported sex/gender (in therespective fields) who are Asian and of unknown/not reported ethnicity.
These are required fields.

Native Hawaiian or Other
Pacific IslanderEnter the number of females, males, and individuals of unknown/not
reported sex/gender (in the respective fields) who are Native Hawaiian or
Other Pacific Islander and Not Hispanic or Latino, and; enter the numberof females, males, and individuals of unknown/not reported sex/gender (inthe respective fields) who are Native Hawaiian or Other Pacific Islander
and Hispanic or Latino; and enter the number of females, males, andindividuals of unknown/not reported sex/gender (in the respective fields)
who are Native Hawaiian or Other Pacific Islander and of unknown/not
reported ethnicity. These are required fields.

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Black or African American

Enter the number of females, males, and individuals of unknown/not
reported sex/gender (in the respective fields) who are Black or African
American and Not Hispanic or Latino, and; enter the number of females,
males, and individuals of unknown/not reported sex/gender (in therespective fields) who are Black or African American and Hispanic or
Latino; and enter the number of females, males, and individuals of
unknown/not reported sex/gender (in the respective fields) who are Blackor African American and of unknown/not reported ethnicity. These are
required fields.

White

Enter the number of females, males, and individuals of unknown/not
reported sex/gender (in the respective fields) who are White and Not
Hispanic or Latino, and; enter the number of females, males, andindividuals of unknown/not reported sex/gender (in the respective fields)
who are White and Hispanic or Latino; and enter the number of females,
males, and individuals of unknown/not reported sex/gender (in therespective fields) who are White and of unknown/not reported ethnicity.
These are required fields.

More than One RaceEnter the number of females, males, and individuals of unknown/not
reported sex/gender (in the respective fields) who identify with more than
one racial category and are Not Hispanic or Latino, and; enter the numberof females, males, and individuals of unknown/not reported sex/gender (inthe respective fields) who identify with more than one racial category andare Hispanic or Latino; and enter the number of females, males, andindividuals of unknown/not reported sex/gender (in the respective fields)
who identify with more than one racial category and of unknown/not
reported ethnicity. These are required fields.

Unknown or Not Reported

Enter the number of females, males, and individuals of unknown/not
reported sex/gender (in the respective fields) whose race is unknown/not
reported and who are Not Hispanic or Latino, and; enter the number offemales, males, and individuals of unknown/not reported sex/gender (inthe respective fields) whose race is unknown/not reported and who are
Hispanic or Latino; and enter the number of females, males, andindividuals of unknown/not reported sex/gender (in the respective fields)
who are of unknown/not reported race and of unknown/not reported
ethnicity. These are required fields.

Total

The total fields at the bottom are auto-calculated to total all racial
categories for females, males, and individuals of unknown/not reported
sex/gender who are Not Hispanic or Latino; all racial categories forfemales, males, and individuals of unknown/not reported sex/gender who
are Hispanic or Latino, and all racial categories for females, males, andindividuals of unknown/not reported sex/gender who are of unknown/not
reported ethnicity. The total fields at the right are auto-calculated to total
all individuals in a given racial category.

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6. Peer Review Process
Overview
NIH policy is intended to ensure that applications for funding submitted to the NIH are evaluated on thebasis of a process that is fair, equitable, timely, and conducted in a manner free of bias. The NIH dual
peer review system is mandated by statute in accordance with section 492 of the Public Health Service
Act and federal regulations governing "Scientific Peer Review of Research Grant Applications andResearch and Development Contract Projects" (42 CFR part 52h).
The first level of review is carried out by a Scientific Review Group (SRG) composed primarily of nonfederal scientists who have expertise in relevant scientific disciplines and current research areas. The
second level of review is performed by Institute and Center (IC) National Advisory Councils or Boards.
Councils composed of both scientific and lay members are chosen for their expertise, interest, or activity
in matters related to health and disease. Only applications that are favorably recommended by both the
SRG and the Advisory Council (or the IC in the case of fellowships) are considered for funding. Only theNIH Institute or Center may make funding decisions.
NIH has implemented Special Council Review procedures for the additional review of grant andcooperative agreement applications from Program Director(s)/Principal Investigator(s) [PD(s)/PI(s)] who
already receive in excess of $1 million per year in total costs to determine if additional funds should be
provided to already well-supported investigators. It is important to note that the Special Council Review
does not represent a cap on total NIH funding for any one investigator. For additional information, please
see NOT-OD-12-110 and NOT-OD-12-140.
A detailed description of what happens to a research project grant application at NIH after it is received
for peer review can be found at the following location:
http://grants.nih.gov/grants/peer_review_process.htm.
Additional information about charters and membership of SRGs, Councils, and Boards can be obtained
from the appropriate Institute, Center, or Office. Information on CDC review procedures is located at
http://www.cdc.gov/phpr/science/erp_policies.htm.
Streamlining
The initial scientific peer review of most applications will also include a process in which only those
applications deemed by the reviewers to have the highest scientific and technical merit, generally thebetter half of the applications under review, will be discussed at the SRG meeting, assigned an impact
score, and receive a second level review. Applications in the lower half are reviewed by SRG members
but they are not discussed or assigned overall impact scores at the SRG meeting. This process allows thereviewers to focus their discussion on the most meritorious applications.
Before the review meeting, each reviewer and discussant assigned to an application will give a separate
score for each of (at least) five review criteria and a preliminary impact score for that application (seebelow). The preliminary impact scores help the SRG to determine which applications will be discussed.
Scoring
Each FOA specifies all of the review criteria and considerations that will used in the evaluation of
applications submitted for that FOA; RFAs and other types of funding opportunities (e.g., for construction
or fellowship applications) may include different and/or additional review criteria and considerations.
SRG members are instructed to evaluate research applications by addressing the scored review criteria(see below) and additional review criteria as applicable for the application.

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For each application that is discussed, a final overall impact/priority score will be given by each eligible
committee member (without conflicts of interest) following the panel discussion. Each member’s impact
score will reflect his/her evaluation of the potential overall impact of the project in its entirety, rather thanan arithmetic formula applied to the reviewer’s scores given to each criterion. The final impact score foreach discussed application will be determined by calculating the arithmetic average of all the eligible
members’ impact scores, and multiplying the average by 10.
As part of the initial merit review, and regardless of whether an application is discussed or not discussed(streamlined), all applicants will receive a written critique, called a Summary Statement. Unless statedotherwise in the FOA, the Summary Statement represents a combination of the reviewers' writtencomments and scores for individual criteria. The Summary Statement for discussed applications includes
the Scientific Review Officer's summary of the members' discussion during the SRG meeting; the final
impact score; the recommendations of the SRG, including budget recommendations; and administrativenotes of special considerations. For applications that are not discussed by the full committee, the scores of
the assigned reviewers and discussants for the five scored criteria will be reported individually on theSummary Statement. Final, numerical impact scores are not given for applications that are not discussed.
Research Project Evaluation Criteria
Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of
the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, inconsideration of the following scored review criteria, and additional review criteria (as applicable for the
project proposed).
Scored Review Criteria. Reviewers will consider each of the five review criteria below in thedetermination of scientific and technical merit, and give a separate score for each. An application does notneed to be strong in all categories to be judged likely to have major scientific impact. For example, aproject that by its nature is not innovative may be essential to advance a field.
Significance: Does the project address an important problem or a critical barrier to progress in thefield? If the aims of the project are achieved, how will scientific knowledge, technical capability,
and/or clinical practice be improved? How will successful completion of the aims change theconcepts, methods, technologies, treatments, services, or preventative interventions that drive thisfield?
Investigator(s): Are the PD/PIs, collaborators, and other researchers well suited to the project? If
Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they
have appropriate experience and training? If established, have they demonstrated an ongoing recordof accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI,
do the investigators have complementary and integrated expertise; are their leadership approach,governance and organizational structure appropriate for the project?
Innovation: Does the application challenge and seek to shift current research or clinical practiceparadigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, orinterventions? Are the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new
application of theoretical concepts, approaches or methodologies, instrumentation, or interventions
proposed?
Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate toaccomplish the specific aims of the project? Are potential problems, alternative strategies, andbenchmarks for success presented? If the project is in the early stages of development, will thestrategy establish feasibility and will particularly risky aspects be managed?

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If the project involves human subjects and/or NIH-defined clinical research, are the plans to address
1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) ofindividuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion ofchildren, justified in terms of the scientific goals and research strategy proposed?
Environment: Will the scientific environment in which the work will be done contribute to theprobability of success? Are the institutional support, equipment and other physical resources
available to the investigators adequate for the project proposed? Will the project benefit from uniquefeatures of the scientific environment, subject populations, or collaborative arrangements?
Additional Review Criteria. As applicable for the project proposed, reviewers will consider thefollowing additional items in the determination of scientific and technical merit, and in providing an
overall impact/priority score, but will not give separate scores for these items.
Appropriate Representation (for Conference Grant Applications): How well do the plans forinclusion of women, racial/ethnic minorities, persons with disabilities, and other individuals who
traditionally have been underrepresented in science provide for their appropriate representation in
the planning, organization, and execution of the proposed conference/scientific meeting? For more
information, visit Inclusion of Women, Minorities and Persons with Disabilities in NIH-Supported
Conference Grants
Protections for Human Subjects: For research that involves human subjects but does not involve
one of the six categories of research that are exempt under 45 CFR part 46, the committee will
evaluate the justification for involvement of human subjects and the proposed protections fromresearch risk relating to their participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4)
importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories
of research that are exempt under 45 CFR part 46, the committee will evaluate: 1) the justification
for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
For additional information on review of the Human Subjects section, please refer to the Human
Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children: When the proposed project involves human subjects
and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the
inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as theinclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals andresearch strategy proposed. For additional information see the Human Subjects Protection andInclusion Guidelines.
Vertebrate animals: The committee will evaluate the involvement of live vertebrate animals as partof the scientific assessment according to the following five points: 1) proposed use of the animals,
and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals andfor the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4)
procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the
conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing
drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection
if not consistent with the AVMA Guidelines on Euthanasia. For additional information, see
http://grants.nih.gov/grants/olaw/VASchecklist.pdf.
Biohazards: Reviewers will assess whether materials or procedures proposed are potentiallyhazardous to research personnel and/or the environment, and if needed, determine whether adequate
protection is proposed.

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Resubmission Applications: When reviewing a Resubmission application the committee will
evaluate the application as now presented, taking into consideration the response to comments fromthe previous scientific review group and changes made to the project.
Renewal Applications: When reviewing a Renewal application, the committee will consider the
progress made in the last funding period.
Revision Applications: When reviewing a Revision application, the committee will consider theappropriateness of the proposed expansion of the scope of the project. If the Revision application
relates to a specific line of investigation presented in the original application that was notrecommended for approval by the committee, then the committee will consider whether the
responses to comments from the previous scientific review group are adequate and whether
substantial changes are clearly evident.
Additional Review Considerations. As applicable for the project proposed, reviewers will address eachof the following items, but will not give scores for these items and should not consider them in providing
an overall impact score.
Provision of Family Care Facilities (for Conference Grant Applications). Are the plans to inform
attendees about family care resources adequate?
Applications from Foreign Organizations. Reviewers will assess whether the project presents
special opportunities for furthering research programs through the use of unusual talent, resources,
populations, or environmental conditions that exist in other countries and either are not readily
available in the United States or augment existing U.S. resources.
Select Agent Research. Reviewers will assess the information provided in this section of theapplication, including 1) the select agent(s) to be used in the proposed research, 2) the registration
status of all entities where select agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of select agent(s), and 4) plans for appropriate biosafety, biocontainment,
and security of the select agent(s).
Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing
Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data
Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2)
Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html);
and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/noticefiles/NOT-OD-07-088.html).
Budget and Period of Support. Reviewers will consider whether the budget and the requested periodof support are fully justified and reasonable in relation to the proposed researchDual-Level Peer Review
The second level of review will usually be performed by the Advisory Council or Board of the potential
awarding component (Institute, Center, or other unit). Council or Board recommendations are based not
only on considerations of scientific merit, as judged by the SRGs, but also on the relevance of the
proposed study to an Institute/Center’s mission, programs and priorities.
NIH has implemented Special Council Review procedures for the additional review of grant andcooperative agreement applications from Program Director(s)/Principal Investigator(s) [PD(s)/PI(s)] who
already receive in excess of $1 million per year in total costs to determine if additional funds should be
provided to already well-supported investigators. It is important to note that the Special Council Review
does not represent a cap on total NIH funding for any one investigator. For additional information, please
see NOT-OD-12-110 and NOT-OD-12-140.

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7.

Supplemental Instructions to the SF 424(R&R) for
Preparing an Individual Research Career
Development Award (CDA) Application(“K” Series)

7.1 Introduction
All applicants must use the SF 424 R&R Application for Federal Assistance, following the instructional
information in this Application Guide. The supplemental instructions found in this section (I.7) are for
Individual Career Development Award (CDA) series applications and include guidance and instructional
information only when there is a difference in the required information to be submitted or there is a needfor more specificity for the individual K program. Therefore, these supplemental instructions must be
used along with the information found in Parts I.1 – I.6 of this document.
These instructions do not cover applications for K12 and other institutional career development programs.
Institutions planning such applications should consult the applicable Funding Opportunity Announcement(FOA) concerning eligibility, award criteria, and application procedures. Some K-series funded through
Requests for Applications (RFAs) may have special instructions.
It is imperative that applicants become familiar with the K activity code for which support is being
requested. Before applying for a K award, applicants should carefully review the applicable FOA for the
career award of interest, noting especially the eligibility requirements, requirements for a mentor, review
criteria, award provisions, and any special application instructions. Each FOA contains more specificinformation associated with the award mechanism and includes names of individuals that may becontacted prior to submission of an application for additional or clarifying information.
The eligibility criteria, support levels, and other important aspects of specific career awards, including
availability, may vary among NIH Institutes or Centers and other PHS agencies. For this reason, it isstrongly recommended that applicants consult with the NIH Scientific/Research contact of the appropriate
awarding component prior to submitting an application. FOAs and other guidelines are available on the
NIH K-Kiosk website http://grants.nih.gov/training/careerdevelopmentawards.htm. Announcements forvarious career award opportunities are issued periodically in the NIH Guide for Grants and Contracts, aweekly electronic publication (http://grants.nih.gov/grants/guide/index.html).
Note: A few 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 forthese awards. The FOA will include any additional and/or specific instructions that must be followed
when applying for such support.

7.2 Individual Career Development Award Programs
The following chart provides a summary of the existing Career Development programs. Since thisinformation is subject to change, prospective applicants are encouraged to review the K-Kiosk for themost current program information. The K-Kiosk includes information on NIH-wide Parent FOAs as well
as IC-specific FOAs for a particular K program.

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Summary of Research Career Development Award Programs
PROGRAMDESCRIPTIONMENTOR

REFERENCELETTERS

K01

Mentored Research Scientist Development Award (see K Kiosk)

Yes

Yes

K02

Independent Scientist Award (see K Kiosk)

No

No

K05

Senior Scientist Award (see K Kiosk)

No

No

K07

Academic Career Award (see K Kiosk)

*

*

K08

Mentored Clinical Scientist Development Award (see K Kiosk)

Yes

Yes

K18

Career Enhancement Award (see K Kiosk)

Yes

Yes

K22

Career Transition Award (see K Kiosk)

*

Yes

K23

K23 Mentored Patient-Oriented Research Career Development Award(see K Kiosk)

Yes

Yes

K24

Mid-Career Investigator Award in Patient Oriented Research (see K
Kiosk)

No

No

K25

Mentored Quantitative Research Career Development Award (see K
Kiosk)

Yes

Yes

K26

Midcareer Investigator Award in Mouse Pathobiology Research (see K
Kiosk)

No

No

K99/R00

NIH Pathways to Independence (PI) Award (see K Kiosk)

Yes

Yes

*Varies with career status and source of award. Check the Funding Opportunity Announcement (FOA).

7.3 Letters of Reference (must be submitted electronicallythrough the eRA Commons)At least three (but no more than 5) Letters of Reference are required for all applications defined as New
and Resubmissions (see Note below) for mentored support as indicated in the table above. The lettersshould be from individuals not directly involved in the application, but who are familiar with theapplicant’s qualifications, training, and interests. The mentor/co-mentor(s) of the application cannot becounted toward the three required references. It is important for the applicant to include the names of
those individuals in the application so that the NIH staff will be aware of planned reference letter
submissions. Within the application, the list of referees (including name, departmental affiliation, andinstitution) is included in Other Attachments on the Other Project Information Form (see special K
instructions in Section 7.4.3). In addition, applicants must include the same list and information on theSF424 (R&R) Cover Form in the Cover Letter Attachment.
The reference letters are critically important and should address the candidate's competence and potential
to develop into an independent biomedical or behavioral investigator. Only those individuals who canmake the most meaningful comments about the candidate's professional training and qualifications for a
research career should be used as referees. Where possible, some referees who are not from thecandidate's current department or organization, but are knowledgeable about their qualifications, should
be selected.

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Letters of Reference are due by the application receipt deadline date. Although previously NIH provided a
5 business days grace period for the receipt of letters of reference after the application receipt due date,
the new policy eliminates the grace period. More information can be found in NIH Guide Notice NOTOD-11-079.
The candidate should request reference letters only from individuals who will be able to submit them to
the NIH at the time of the application submission due date (see NOT-OD-11-079).
Applications that are missing the required letters of reference may be delayed in review or may not be
accepted.
Note: For resubmission applications, it is critical that NEW Letters of Reference be submitted providing
up-to-date evaluation of the applicant’s potential to become an independent researcher, and the continued
need for additional supervised research experience.
Electronic submission of a letter of reference is a separate process from submitting an applicationelectronically. Reference letters are submitted directly through the eRA Commons and do not use
Grants.gov. Therefore, this process requires that the referee be provided information including (a) the PI’s(candidate’s) eRA Commons user name, (b) the PI’s first and last name as they appear on the PI’s eRA
Commons account, and (c) the number assigned to this Funding Opportunity Announcement.
Confirmation e-mails will be sent to both the referee and the candidate following reference letter
submission. The confirmation sent to the candidate will include the referee’s name and the date the letter
was submitted. The confirmation sent to the referee will include the referee and applicant’s names, aconfirmation number, and the date the letter was submitted.
The candidate may check the status of submitted letters by logging into their Commons account andaccessing the “check status” screen for this application. The candidate is responsible for reviewing thestatus of submitted reference letters and contacting referees to ensure that letters are submitted by thereceipt deadline. While the candidate is able to check on the status of the submitted letters, the letters are
confidential and he/she will not have access to the letters themselves. Note: Because e-mail can be
unreliable, it is the candidate’s responsibility to check the status of his/her letters of reference in the
Commons.
Candidates should provide the following instructions to their referees.
Instructions for Referees: (these instructions are also found at:
http://grants.nih.gov/grants/funding/424/Referee_Instructions_Mentored_Career_Awards.doc)
Name of Candidate (First & Last Name as shown in the eRA Commons): _______________
Candidate’s eRA Commons UserName: _______________
FOA Number: __________________________
The candidate is applying to the NIH for a Career Development Award. The purpose of this award is todevelop the research capabilities and career of the candidate. These awards provide salary support andguarantee them the ability to devote at least 9 person months (75% of their total professional effort) toresearch for the duration of the award. Many of these awards also provide funds for research and careerdevelopment costs. The award is available to persons who have demonstrated considerable potential to
become independent researchers, but who need additional supervised research experience in a productive
scientific setting, as well as to newly independent researchers.
In two pages or less (PDF format), describe the qualities and potential of the candidate for the careerdevelopment award program for which support is being requested. This should include your evaluation
with special reference to:•potential to become an independent research scientist;

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evidence of originality;•

adequacy of scientific background;•

quality of research endeavors or publications to date, if any;•

commitment to health-oriented research; and•need for further research experience and training•

any additional related comments that the referee may wish to provide

Please put the name of the candidate at the top of the letter. Also, be sure to include your name and title in
the letter.
Submitting Reference Letters
Letters must be submitted directly to the eRA Commons at:https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new and must be
submitted by the application receipt deadline date. More information can be found in NIH Guide Notice
NOT-OD-11-079.
You will be requested to enter the following information on-line at the time of submission:
Referee Information:•

Referee First Name (Required)•

Referee Last Name Required)•

Referee MI Name (Not Required)•

Referee e-mail (Required)•

Referee institution/affiliation (Required)•

Referee department (Required)

Candidate Information:•

PI Commons User ID (Required)•

PI’s last name, as it appears on the PI’s Commons account (Required) (will be validated to ensure
they match)•

Funding Opportunity Announcement (FOA) Number (Required)•

Reference letter confirmation number (Required only if resubmitting a letter; not required
otherwise)•

Reference letter – two pages maximum; PDF format

After you have submitted your letter, both you and the candidate will receive a confirmation of receipt bye-mail. The confirmation sent to the candidate will include your name and the date your letter was
submitted. However, the letters are confidential and the candidate will not be able to access the lettersthemselves. Your e-mail confirmation will include a Reference Letter Submission Confirmation Number.
The Confirmation Number will be required when resubmitting letters for the current round. Please print
the confirmation e-mail for your records.
Revised reference letters may be submitted at the time of the application receipt date.

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7.4 K- Specific Instructions for K Applications using theSF424 (R&R) Application
Standard Instructions found in Parts I.1 – I.6 should be followed with the exceptions found in this section.
Section numbers referenced below (e.g. 4.2 – 5.6) reflect those found in Part I.

7.4.1 Special Instructions for 4.2 Cover Form
Type of Application: Unless stated in the applicable FOA, individual K awards are usually notrenewable nor are they supplemented/revised (contact awarding form staff if clarification is needed).
Therefore, the applicant should generally check “new” or “resubmission.” “Renewal” applications are
accepted only for a few K programs; thus this value should only be checked if a specific FOA states
Renewals are accepted.
Proposed Project (Start and Ending Dates): The requested period of support must be within specified
limits for the type of K award requested.
Project Director/Principal Investigator (PD/PI) Contact Information: Provide the name of theindividual candidate (considered the PD/PI for K award programs). If the candidate is not located at theapplicant organization at the time the application is submitted, the information should reflect where thecandidate can be reached prior to the requested award start date. If the PD/PI is not located at theapplicant organization at the time of submission, the Commons account for the PD/PI must be affiliatedwith the applicant organization. For additional information on creating affiliations for users in the eRA
Commons, see: https://commons.era.nih.gov/commons-help/175.htm.
Note: For some career transition award programs (e.g., K22) the applicant may apply WITHOUT an
institutional affiliation. These individuals should refer to the specific funding opportunity announcement(FOA) for application instructions.
Cover Letter Attachment
Mentored CDA applicants must include a cover letter. Applicants for independent CDAs are encouraged
to include a cover letter with the application. The cover letter is only for internal use and will not beshared with peer reviewers. For mentored CDA applications, the cover letter must contain the same list ofReferees (including name, departmental affiliation, and institution) that is included in the Other Project
Information Form. Other Attachment (see Part I Section 7.4.3).
For both mentored and non-mentored K applications, the cover letter can also include the information
found in Part I.4.2.

7.4.2 Special Instructions for 4.3 Research & Related
Project/Performance Site Locations Form
Indicate where the work described in the Research and Career Development Plans will be conducted.

7.4.3 Special Instructions for 4.4 Other Project Information Form
Project Summary/Abstract (Do not exceed 1 page): Provide an abstract of the entire application(candidate, environment, and research). Include the candidate's immediate and long-term career goals,
key elements of the research career development plan, and a description of the research project, as
indicated in Part I.4.4.6.
Facilities & Other Resources: Provide in the Attachment a detailed description of the institutional
facilities and resources available to the candidate, following the instructions in Part I.4.4.10. The

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information provided is of major importance in establishing the feasibility of the goals of the careerdevelopment plan.
Other Attachments: All mentored K applications must include a list of Referees here. The list should
include the name of the referee, departmental affiliation and institution. This same list must also be
provided in the Cover Letter.

7.4.4 Special Instructions for 4.5 Senior/Key Person Profile(s) Form
7.4.4.1

The Candidate

For all K applications the K candidate is considered the Project Director/Principal Investigator (PD/PI).
Therefore the candidate must be registered in the eRA Commons and be assigned the PI role within the
Commons. Follow the instructions in Part I.2 which provides information regarding required registrationin the eRA Commons.
Note that agency policies concerning “Multiple PIs” are not applicable to K applications. Therefore, do
not use the PD/PI role for any other senior/key personnel.
Candidate’s Biographical Sketch
A biographical sketch attachment is required for the K candidate. Follow the page limits for the biosketchin the table of page limits (Table 2.6-1), unless specified otherwise in the FOA.
A biosketch for the K applicant should follow the instructions below:
Position Title: If the candidate is not currently located at the applicant organization, include both“current” and “projected” position titles, labeling each accordingly.
Education: Complete the educational block at the top of the format page beginning with thebaccalaureate or other initial professional education, such as nursing, and include postdoctoral training;
separately referencing residency training when applicable. For each entry provide the name and locationof the institution;, the degree received (if applicable); the month and year the degree was received, and thefield of study. For residency entries, the Field of Study section should reflect the area of residency. For
non-degree education, indicate the time period covered. List professional certifications received within
the last 10 years.
Personal Statement: Briefly describe why your experience and qualifications make you particularly
well-suited to receive the K award for which you are applying.
Research and/or Professional Experience:
Use the headings given below instead of the instructions on the Biographical Sketch Format Page.
Identify each heading.
Employment
Start with the first position held following the baccalaureate and give a consecutive record to date.
Indicate the department and organization, department head or supervisor, rank, tenured or non-tenured,
status (full- or part-time), and inclusive dates (month and year). When applicable, include information on
military service, and, if not referenced under Education above, internships, residencies, research
assistantships, fellowships, etc. If the candidate is not currently located at the applicant organization,
include the projected employment position in this section as well.

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HonorsList academic and professional honors chronologically, including research grants and competitive
fellowships awarded to the candidate.
Professional Societies and Public Advisory Committees
Identify professional societies and related organizations in which membership has been held within thelast 10 years, giving dates. Include present membership on any Federal Government public advisorycommittee.
Publications and Patent Citations
NIH encourages applicants to limit the list of selected peer-reviewed publications or manuscripts in press
to no more than 15. The individual may choose to include selected publications based on recency,
importance to the field, and/or relevance to the candidate’s proposed research. Candidates without 15
publications may substitute the following in lieu of publications:oOriginal research and theoretical treatises;oNon-experimental articles, e.g., review of literature in field, book chapters, etc.;oBooks, pamphlets, etc.

For each publication, list the authors in published sequence, full title of article, journal, volume number,
page numbers, and year of publication. Indicate if you previously used another name that is reflected inany of the citations. URLs or NIH PubMed Central (PMC) submission identification numbers may be
included along with the full reference. While there is no limit to the number of URLs or PMC submission
identification numbers that can be cited, applicants should be both judicious and concise.
Do not include manuscripts submitted or in preparation.
When citing articles that fall under the Public Access Policy, were authored or co-authored by theapplicant and arose from NIH support, provide the NIH Manuscript Submission reference number (e.g.,
NIHMS97531) or the PubMed Central (PMC) reference number (e.g., PMCID234567) for each article. If
the PMCID is not yet available because the Journal submits articles directly to PMC on behalf of theirauthors, indicate "PMC Journal - In Process." A list of these Journals is posted at:
http://publicaccess.nih.gov/submit_process_journals.htm. Citations that are not covered by the Public
Access Policy, but are publicly available in a free, online format may include URLs or PubMed ID(PMID) numbers along with the full reference (note that copies of publicly available publications are notaccepted as appendix material.)
Research Support
List both selected ongoing and completed (during the last three years) research projects (Federal or nonFederal support). Begin with the projects that are most relevant to the research proposed in thisapplication. Briefly indicate the overall goals of the projects and responsibilities of the senior/key person
identified on the Biographical Sketch. Do not include number of person months or direct costs.
Don’t confuse “Research Support” with “Other Support.” Though they sound similar, these parts of theapplication are very different. As part of the biosketch section of the application, “Research Support”
highlights your accomplishments, and those of your colleagues, as scientists. This information will be
used by the reviewers in the assessment of each individual’s qualifications for a specific role in the
proposed project, as well as to evaluate the overall qualifications of the research team. In contrast, “Other
Support” information is required for all applications that are selected to receive grant awards. NIH staff

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will request complete and up-to-date “other support” information from you after peer review. This
information will be used to check that the proposed research has not already been Federally-funded.
7.4.4.2

Mentor, Co-mentor, and Other Senior/Key Persons

The mentored K awards require a primary mentor, and there may be co-mentor(s), consultants andcontributors. All individuals who have committed to contribute to the scientific development andexecution of the project, including mentors and co-mentors, should be identified as senior/key personnel,
even if they are not committing any specified measurable effort to the proposed project. Mentors and comentors should be assigned the Project Role of “Other Professional” and then enter “Mentor” or “Comentor” in the Other Project Role Category field.
Consultants should also be assigned the “Other Professional” role even if they are not committing any
specified measurable effort. Then, enter the specific project role under “Other Project Role Category.”
Any individuals identified as senior/key personnel who are committing specified measurable effort should
be appropriately assigned under Project Role (and Other Project Role Category, if necessary). Additional
information can be found in Section 4.5.1.
Current and Pending Support for Mentors/Co-mentors: For Mentored Career Development Awards,
as part of the application submission modified Current and Pending Support pages must be submitted forthe mentor and co-mentor(s), but not for the candidate, on the R&R Senior/Key Person Profile(Expanded) page. Provide information on the following selected items for the mentor’s and co-mentor’scurrent and pending research support relevant to the candidate’s research plan. Each attachment is limited
to 4 pages. Note, Current and Pending Support for the Candidate will be requested on a Just-In-Timebasis.
Special Instructions for Selected Items of Current & Pending Support for Mentor/Co-Mentors
Project Number: If applicable, include a code or identifier for the project.
Source: Identify the agency, institute, foundation, or other organization that is providing the support.
Major Goals: Provide a brief statement of the overall objectives of the project, subproject, or
subcontract.
Dates of Approved/Proposed Project: Indicate the inclusive dates of the project as approved/proposed.
For example, in the case of NIH support, provide the dates of the approved/proposed competitive
segment.
Annual Direct Costs: In the case of an active project, provide the current year’s direct cost budget. For apending project, provide the proposed direct cost budget for the initial budget period.
Do not include information on overlap and level of effort.
For non-mentored CDAs: Candidates for non-mentored CDAs should not submit Other Support Pages
at the time of application unless specified to do so in the applicable FOA.
Updated information on all active support for the candidate, mentor(s), co-mentor(s), and senior/key
personnel may be requested by the awarding component prior to award.
Biographical Sketch for Mentor/Co-mentor and Other Senior/Key Person: For the biographicalsketch for all individuals other than the candidate, follow the biographical sketch instructions found inPart I.4.5.
Note: K22 and K99/R00 candidates should follow instruction in the specific FOA regarding senior/key
personnel.

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7.4.5 Special Instructions for 4.6 Selecting the Appropriate BudgetForm
K award mechanisms are not modular; therefore, only the R&R budget form is applicable and only a few
budget categories are actually used. Information regarding allowable costs for the candidate and any
allowable research development or other costs is included in each K program FOA. Candidates areadvised to contact the targeted awarding component if uncertain about allowable amounts for theapplicable K award mechanism, keeping in mind that amounts vary with awarding components. The
application forms package associated with CDA funding opportunities includes the R&R Budget Form.
Instructions for completing the R&R Budget Form are provided below. Additional guidance may also be
provided in the specific funding opportunity announcement.
Note: NIH intramural candidates applying for transitional career award support (e.g., K22, K99/R00)
should follow instructions in the applicable FOA. For the mentored phase of these awards, budgets arenegotiated with the sponsoring intramural laboratory. For awardees who receive approval to transition to
the extramural phase, a budget will be required as part of the extramural sponsored application.

7.4.6 Special Instructions for 4.7 R&R Budget Form
Follow the instructions provided in Part I.4.7 with the following exceptions:4.7.1. A. Senior/Key Person: In general this section should include the name of the candidate only. Do
not include the mentor(s) or any other senior/key persons. For the candidate, provide the base salary,person months, and requested salary and fringe benefits. For person months, be reminded that K programs
include a minimum effort requirement, usually 75% or 9 academic person months. For the salary column,
most NIH ICs limit the amount of salary provided for K programs. However, applicants should include
information on actual institutional base salary and the actual amount of salary and fringe being requested.
ICs may request updated salary information prior to award. Any adjustments based on policy limitations
will be made at the time of the award.
4.7.1. B. Other Personnel: In general, leave this section blank.
4.7.2. C – E: Leave these sections blank.
4.7.3 F. Other Direct Costs: In the Material and Supplies field (F.1), enter the total researchdevelopment support being requested for the initial year of the K award. Usually, a specific total amountis allowed for research development and other costs (tuition, fees, research supplies, equipment, computer
time, travel, etc) that do not require individual cost category identification. Unless instructed differently inthe applicable FOA, applicants should enter only the total requested research development support
amount in this box. All remaining budget fields in this section should be left blank.
Please note that while this method of entering only the total requested research development support(RDS) costs in section F will be simplest for most applicants, some applicants, including some system-tosystem applicants, may instead choose to enter those costs in the applicable detailed budget categories.
Please note that when choosing this option it is still the applicant’s responsibility to make certain the total
RDS costs do not exceed the allowable total. If there are no costs within the research development support
costs that affect the Indirect Cost Base calculation, the total RDS should be entered in total in F.1.
4.7.3. H. Indirect Costs: For all K applications, F&A/indirect costs are reimbursed at 8% of modified
total direct costs (exclusive of tuition and fees and expenditures for equipment) rather than on the basis ofa negotiated rate agreement. Follow the instructions in the chart below for completing this section.

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Field Name

Instructions

Indirect Cost Type

Indicate the Indirect Cost type as Modified Total Direct Costs.

Indirect Cost Rate (%)

Indicate the indirect cost rate (also known as Facilities & Administrative
Costs [F&A]) as 8%.

Indirect Cost Base ($)

Enter the amount of the base for the indirect cost type.

Funds Requested

Enter the funds requested for the indirect cost type.

Total Indirect Costs

The total funds requested for indirect costs.

Cognizant Federal Agency

Enter “Not Applicable.” Alternatively, applicants may provide the nameof the cognizant Federal agency, name, and phone number of theindividual responsible for negotiating your rate. Either response isacceptable since indirect costs will be reimbursed as 8% of modified total
direct costs rather than on the basis of a negotiated rate agreement.

4.7.3.K Budget Justification: Use this to provide a detailed description and justification for specificitems within the Research Development Support costs; e.g., all equipment, supplies, and other personnel
that will be used to help achieve the career development and research objectives of this award.

7.4.7 Special Instructions for 5. Completing PHS 398 Forms
5.1 Overview
In conjunction with the SF424 (R&R) forms, NIH and other PHS agencies grants applicants should also
complete and submit additional forms titled “PHS 398.” Note the PHS 398 forms include additional datarequired by the agency for a complete application. While these are not identical to the PHS 398
application form pages, the PHS 398 reference is used to distinguish these additional data requirementsfrom the data collected in the SF424 (R&R) forms. A complete application to NIH and other PHS
agencies will include SF424 (R&R) and PHS 398 forms. The PHS 398 forms for the individual K
programs include:•

PHS 398 Cover Page Supplement (I.5.3): this supplements the data requirements in the R&R
Cover Form. Follow the instructions found in Part I.5.3 and in the K specific instructions below.

•

PHS 398 Career Development Award Supplemental Form (I.7.5)

Complete each form using the instructions found in Part I.5 and the K specific instructions provided
below.
5.3 Cover Page Supplement Form
7. Change of Investigator / Change of Institution Questions: A change in PD/PI is not allowed
for K awards.

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7.5 PHS 398 Career Development Award Supplemental Form

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The PHS 398 Career Development Award Supplemental Form should include sufficient informationneeded for evaluation of the project, independent of any other document (e.g., previous application). Be
specific and informative, and avoid redundancies. Some sections are required for all K award applications
and some sections are only to be used when required by the FOA. Be sure to read all instructions in the
FOA before completing this section since errors could lead to incomplete or rejected applications.
Career Development Award Attachments (See also Section 2.3.2 Creating PDFs for Text Attachments)
Although many of the sections of this application are separate PDF attachments, page limits referenced in
the instructions and/or funding opportunity announcement must still be followed. Agency validations will
include checks for page limits (and use of appropriate font). Some accommodation will be made forsections that, when combined, must fit within a specified limitation.
Text attachments should be generated using word processing software and then converted to PDF using
PDF generating software. Avoid scanning text attachments to convert to PDF since that causes problems
for the agency handling the application. In addition, be sure to save files with descriptive file names.
Do not include any information in a header or footer of the attachments. A header will be systemgenerated that references the name of the PD/PI. Page numbers for the footer will be system-generated in
the complete application, with all pages sequentially numbered.
Since a number of reviewers will be reviewing applications as an electronic document and not a paper
version, applicants are strongly encouraged to use only a standard, single-column format for the text.
Avoid using a two-column format since it can cause difficulties when reviewing the document
electronically.
Full-sized glossy photographs of material such as electron micrographs or gels must only be included
within the page limits of the Career Development Award application. The maximum size of images to be
included should be approximately 1200 x 1500 pixels using 256 colors. Figures must be readable as
printed on an 8.5 x 11 inch page at normal (100%) scale.
Candidates must use image compression such as JPEG or PNG. Do not include figures or photographs as
separate attachments either in the Appendix or elsewhere in the application.
Separate Attachments
Separate attachments have been designed for the Career Development Award Supplemental Form
sections to maximize automatic validations conducted by the eRA system. When the application isreceived by the agency, all of the CDA Supplemental Form sections will be concatenated in theappropriate order so that reviewers and agency staff will see a single cohesive application.
When attaching a PDF document to the actual forms, please note you are attaching an actual document,
not just pointing to the location of an externally stored document. Therefore, if you revise the document
after it has been attached, you must delete the previous attachment and then reattach the revised document
to the application form. Use the View Attachment button to determine if the correct version has been
attached.
Page Limits
Follow the page limits for the Career Development Award Supplemental Form in the table of page
limits (Table 2.6-1), unless specified otherwise in the FOA. All tables, graphs, figures, diagrams, andcharts must be included within the 12-page limit (note that this may span to 15 pages in the eRA
Commons application image due to white space inserted at the end of sections when separating files).
Follow page limitations as specified in Funding Opportunity Announcements (FOAs).

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All applications and proposals for NIH funding must be self-contained within specified page limits.
Agency validations will include checks for page limits. Note that while these computer validations will
help minimize incomplete and/or non-compliant applications, they do not replace the validations
conducted by NIH staff. Applications found not to comply with the requirements may be delayed in thereview process. Unless otherwise specified in an NIH solicitation, internet website addresses (URLs) may
not be used to provide information necessary to the review because reviewers are under no obligation toview the internet sites. Moreover, reviewers are cautioned that they should not directly access an internet
site as it could compromise their anonymity.
Applicants are prohibited from using the Appendix to circumvent page limitations in any section of theapplication for which a page limit applies.” For additional information regarding Appendix material andpage limits, please refer to the NIH Guide Notice NOT-OD-11-080,
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-080.html.
Notice of Proprietary Information
Applicants are discouraged from submitting information considered proprietary unless it is deemed
essential for proper evaluation of the application. However, when the application contains informationthat constitutes trade secrets, or information that is commercial or financial, or information that isconfidential or privileged, make sure you have checked “Yes” for proprietary/privileged informationquestion in the Other Project Information form.
When information in the application constitutes trade secrets or information that is commercial or
financial, or information that is confidential or privileged, it is furnished to the Government in confidencewith the understanding that the information shall be used or disclosed only for evaluation of thisapplication. However, if a grant is awarded as a result of or in connection with the submission of thisapplication, the Government shall have the right to use or disclose the information to the extent
authorized by law. This restriction does not limit the Government’s right to use the information if it isobtained without restriction from another source.
Although the grantee institution and the PD/PI will be consulted about any such release, the PHS will
make the final determination. Any indication by the applicant that the application contains proprietary or
privileged information does not automatically shield the information from release in response to a
Freedom of Information Act (FOIA) request should the application result in an award (see 45 CFR Part5). If an applicant fails to identify proprietary information at the time of submission as instructed in theapplication guide, a significant substantive justification will be required to withhold the information if
requested under FOIA.
Research Plan
A Research Plan is required for all types of individual K awards. The Research Plan is a major part of theresearch career development plan. It is important to relate the research to the candidate's scientific careergoals. Describe how the research, coupled with other developmental activities, will provide theexperience, knowledge, and skills necessary to achieve the objectives of the career development plan andlaunch and conduct an independent research career, or enhance an established research career. For
mentored K awards, explain the relationship between the candidate’s research on the CDA and thementor’s ongoing research program.
For most types of research, the plan should include: a specific hypothesis; a list of the specific aims andobjectives that will be used to examine the hypothesis; a description of themethods/approaches/techniques to be used in each aim; a discussion of possible problems and how they
will be managed; and, when appropriate, alternative approaches that might be tried if the initialapproaches do not work.

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The Research Plan of a CDA is expected to be appropriate for, and tailored to the experience level of thecandidate, and allow him/her to develop the necessary skills needed for further career advancement, andreviewers will evaluate the plan accordingly. The plan should be achievable within the requested time
period. Pilot or preliminary studies and routine data gathering are generally not appropriate as the solepart(s) of a CDA research plan. Although candidates for mentored K awards are expected to write the
Research Plan, the mentor should review a draft of the plan and discuss it in detail with the candidate.
Review by other knowledgeable colleagues is also helpful. Although it is understood that CDA
applications do not require the extensive detail usually incorporated into regular research applications, afundamentally sound Research Plan and a reasonably detailed Approach section should be provided.
In general, less detail will be expected in descriptions of research planned for the future years of the
proposed CDA. However, sufficient detail should be provided to enable the peer reviewers to determinethat the plans for those years, including the approach to be used, are worthwhile and are likely to enable
the candidate to achieve the objectives of the Research Plan.
The PHS 398 Career Development Award Supplemental Form is comprised of sections for: Candidate
Information; Statement of Support (Mentors); Environment & Institutional Commitment to the Candidate;
and the Research Plan (including Human Subjects and Other Research Plan Sections).
Begin each text section of the Candidate Information and Research Plan with a section header (e.g.,
Introduction, Specific Aims, Background & Significance, etc). See Specific FOA for additional
information.
Field Name

Instructions

1. Introduction to
Application (for
RESUBMISSION
applications only)

NIH policy allows a thirty-seven month window for resubmissions (A1applications) following the submission of a New, Renewal, or Revisionapplication (A0 application). See NIH Notice NOT-OD-12-128 foradditional information/clarification of NIH policy.
Use only if Type of Application is Resubmission. Resubmission
applications must include an Introduction to Resubmission Application,
not to exceed one page. The Introduction must include responses to thecriticisms and issues raised in the Summary Statement. Summarize thesubstantial additions, deletions, and changes. In the body of theapplication, highlight paragraphs with significant changes by bracketingand changing typography.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

Candidate Information
Field Name

Instructions

2. Candidate’s Background

This attachment is required. Follow the page limits for the Career
Development Award Supplemental Form in the table of page limits(Table 2.6-1), unless specified otherwise in the FOA.
Use this section to provide any additional information not described in the
Biographical Sketch Format Page such as research and/or clinical training
experience.

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Field Name

Instructions
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

3. Career Goals andObjectives

This attachment is required. Follow the page limits for the Career
Development Award Supplemental Form in the table of page limits(Table 2.6-1), unless specified otherwise in the FOA.
Describe your past scientific history, indicating how the award fits into
past and future research career development. If there are consistentthemes or issues that have guided previous work, these should be madeclear; if your work has changed direction, the reasons for the change
should be indicated. It is important to justify the award and how it will
enable you to develop or expand your research career. You may include atimeline, including plans to apply for subsequent grant support.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

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

This attachment is required. Follow the page limits for the Career
Development Award Supplemental Form in the table of page limits(Table 2.6-1), unless specified otherwise in the FOA.
Stress the new enhanced research skills and knowledge you will acquire
as a result of the proposed award. If you have considerable researchexperience in the same areas as the proposed research, reviewers may
determine that the application lacks potential to enhance your research
career. For mentored awards, describe structured activities, such as course
work or technique workshops, which are part of the developmental plan.
If course work is included, provide course numbers and descriptive titles.
Briefly discuss each of the activities, except research, in which you expect
to participate. Include a percentage of time involvement for each activity
by year, and explain how the activity is related to the proposed researchand the career development plan.
Note that recipients of mentored K awards may receive concurrent
support from an NIH research grant award or cooperative agreement only
under certain conditions (see NIH Notice NOT-OD-08-065).
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

5. Training in the
Responsible Conduct ofResearch

This attachment is required. Follow the page limits for the Career
Development Award Supplemental Form in the table of page limits(Table 2.6-1), unless specified otherwise in the FOA.
For mentored career development awards, describe a plan to acquire
instruction in the responsible conduct of research. For independent careerawards, describe a plan to obtain or provide instruction in the responsible
conduct of research. See Supplemental Instructions Part III Section 1.16

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Field Name

Instructions
for information on the NIH Policy on Training in the Responsible
Conduct of Research (RCR).
Attach a description of plans for obtaining instruction in the responsible
conduct of research. This section should document prior instruction or
participation in RCR training during the applicant’s current career stage(including the date instruction was last completed) and propose plans toeither receive instruction or participate as a course lecturer, etc., in order
to meet the once every four-year requirement. The plan should address
how applicants plan to incorporate the five instructional parts outlined in
the NIH Policy on Instruction in the Responsible Conduct of Research:format, subject matter, faculty participation, duration, and frequency. The
plan may include career stage-appropriate individualized instruction or
independent scholarly activities that will enhance the applicant’s
understanding of ethical issues related to their specific research activities
and the societal impact of that research. The role of the mentor in RCR
instruction must be described.
Where applicable, Renewal applications must describe the RCR
instruction activities undertaken during the project period as well as futureplans.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

6. Candidate’s Plan toProvide Mentoring(Include only whenrequired by the specific
FOA, e.g., K24 and K05)

The plan should provide information about the candidate’s commitment toserve as a mentor to other investigators, and describe previous mentoring
activities. The plan should describe the setting and provide information
about the available pool of mentees with appropriate backgrounds andinterests in the same field of science. It should also include information on
the candidate’s past and proposed mentees sufficient to evaluate thequality of prior mentoring experiences, including the professional levelsof mentees, and the frequency and kinds of mentoring interactions
between the candidate and the mentees. Describe the productivity of thementoring relationship for the scientific development of the new scientists
as judged by their publications and current research activities. Senior level(K05) candidates should describe any financial and material support fromtheir own funded research and research resources that will be available totheir mentees. The candidate’s proposed percent effort commitment to thementoring plan should also be stated.
Follow the page limits for the Career Development Award Supplemental
Form in the table of page limits (Table 2.6-1), unless specified otherwise
in the FOA. Save this information in a single file in a location you
remember. Click Add Attachment, browse to where you saved the file,select the file, and then click Open.

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Statements and Letters of Support
Field Name

Instructions

7. Plans and Statements ofMentor and Co-mentor(s)This section is to be completed by the mentor and co-mentor(s), asappropriate. The letters must be appended together and uploaded as asingle pdf file. Follow the page limits for the Career Development Award
Supplemental Form in the table of page limits (Table 2.6-1), unlessspecified otherwise in the FOA.
For mentored awards (see Summary of Career Development Award
Mechanisms table), the mentor must explain how they will contribute to
the development of the candidate's research career. This statement should
include all of the following:
1.

The plan for the candidate's training and research careerdevelopment. This description must include not only research, butalso other developmental activities, such as seminars, scientificmeetings, training in the responsible conduct of research, andpresentations. It should discuss expectations for publications over theentire period of the proposed project and define what aspects of the
proposed research project the candidate will be allowed to take withhim/her to start their own research program.

2.

The source of anticipated support for the candidate’s research project
for each year of the award period.

3.

The nature and extent of supervision and mentoring of the candidate,and commitment to the candidate's development that will occur
during the award period.

4.

The candidate's anticipated teaching load for the period of the award(number and types of courses or seminars), clinical responsibilities,
committee and administrative assignments, and the portion of time
available for research.

5.

A plan for transitioning the candidate from the mentored stage of
his/her career to the independent investigator stage by the end of the
project period of the award. The mentor should describe previous
experience as a mentor, including type of mentoring (e.g., graduate
students, career development awardees, postdoctoral students),
number of persons mentored, and career outcomes.

All mentored career development applications should identify any and all
co-mentors involved with the proposed research and career development
program. Co-mentors must specifically address the nature of their role inthe career development plan and how the responsibility for the
candidate’s development is shared with the mentor. Describe respective
areas of expertise and how they will be combined to enhance thecandidate’s development. Also describe the nature of any resources thatwill be committed to this CDA. Letters from the mentor(s) and comentor(s) documenting their role and willingness to participate in the
project must be included in this section of the application. Do not placethese letters in the Appendix.

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Field Name

Instructions
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

8. Letters of Support from
Attach all appropriate letters of support. Letters are not required forCollaborators, Contributors, personnel (such as research assistants) not contributing in a substantive,
and Consultants
measurable way to the scientific development or execution of the project.
For consultants, letters should include rates/charges for consulting
services.
All mentored career development award applications should identify
any and all collaborators, contributors, and consultants involved with theproposed research and career development program not already included
in Item 7. Letters should briefly describe their anticipated contributions
and document their role and willingness to participate in the project.
Additionally, non-mentored career development award applications
should include letters from collaborators, consultants and contributors
listing their proposed roles and documenting their willingness toparticipate in the project. The letters should also briefly describe researchmaterials, data, guidance, or advice each person will provide.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, and the click
Open.
Environment and Institutional Commitment to the Candidate
Field Name

Instructions

9. Description of
Institutional Environment

The sponsoring institution must document a strong, well-establishedresearch program related to the candidate's area of interest, including thenames of key faculty members relevant to the candidate's proposeddevelopmental plan. Referring to the resources description (See section
4.4.10 Facilities and Other Resources), indicate how the necessary
facilities and other resources will be made available for career
enhancement as well as the research proposed in this application.
Describe opportunities for intellectual interactions with otherinvestigators, including courses offered, journal clubs, seminars, andpresentations. This attachment is required and is limited to one page.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

10. Institutional
Commitment to
Candidate’s Research
Career Development

Introduction
The institution should provide a document on institutional letterhead that
describes its commitment to the candidate and the candidate’s careerdevelopment, independent of the receipt of the CDA. The document

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Field Name

Instructions
should include the institution’s agreement to provide adequate time andsupport for the candidate to devote the proposed protected time toresearch and career development for the entire period of the proposedaward. The institution should provide the equipment, facilities, andresources necessary for a structured research career development
experience. It is essential to document the institution's commitment to theretention, development and advancement of the candidate during theperiod of the award.
Because of the diverse types of K awards, applicants should contact theappropriate awarding component Scientific/Research contact listed in thespecific FOA to determine the level of commitment required for thisapplication.
Agreement
The applicant organization must:a.

Agree to release the candidate from other duties and activities todevote the required percentage of time for development of a research
career. For most K awards, commitment of at least 75 percent oftime is required. Describe actions that will be taken to ensure this;e.g., reduction of the candidate's teaching load, committee andadministrative assignments, and clinical or other professional
activities for the current academic year. (For example, describe theactions that will be taken to compensate for the reduction in clinic
responsibilities of the candidate, e.g., hiring of additional staff).
Describe the candidate's academic appointment, bearing in mind thatit must be full-time, and that the appointment (including all rights
and privileges pertaining to full faculty status if in an academic
setting) and the continuation of salary should not be contingent upon
the receipt of this award. Describe the proportion of time currently
available for the candidate's research experience and what thecandidate's institutional responsibilities will be if an award is made.

b.

Provide the candidate with appropriate office and laboratory space,equipment, and other resources and facilities (including access toclinical and/or other research populations) to carry out the proposed
Research Plan.

c.

Provide appropriate time and support for any proposed mentor(s)and/or other staff consistent with the career development plan.

Signatures
The institutional commitment must be dated and signed by the person
who is authorized to commit the institution to the agreements andassurances listed above. In most cases, this will be the dean or thechairman of the department. The signature must appear over the signer's
name and title at the end of the statement. If the candidate will be working
away from the home institution, signatures from both the home and thePart I: Instructions for Preparing and Submitting an Application

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host institution are required.
The sponsoring institution, through the submission of the application andin the institutional commitment section, certifies that all items outlined
above will be provided and that the institution will abide by the applicableassurances and PHS policies. See: NOT-OD-06-054.
This attachment is required and is limited to one page. Create a single fileof the institutional letter and save it in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

Research Plan
Field Name

Instructions

11. Specific Aims

State precisely the goals of the proposed research and summarize theexpected outcome(s) including the impact that the results of the proposed
research will exert on the research field(s) involved.
List succinctly the specific objectives of the research proposed, e.g., totest a stated hypothesis, create a novel design, solve a specific problem,
challenge an existing paradigm or clinical practice, address a criticalbarrier to progress in the field, or develop new technology.
The Specific Aims attachment is required. Follow the page limits for the
Career Development Award Supplemental Form in the table of page
limits (Table 2.6-1), unless specified otherwise in the FOA.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

12. Research Strategy

Follow the page limits for the Career Development Award Supplemental
Form in the table of page limits (Table 2.6-1), unless specified otherwise
in the FOA.
Organize the Research Strategy in the specified order and using the
instructions provided below. Start each section with the appropriate
section heading – Significance, Innovation, Approach. Cite publishedexperimental details in the Research Strategy section and provide the fullreference in the Bibliography and References Cited section (Part I Section
4.4.9).
1. Significance•••

Explain the importance of the problem or critical barrier toprogress in the field that the proposed project addresses.
Explain how the proposed project will improve scientificknowledge, technical capability, and/or clinical practice in
one or more broad fields.
Describe how the concepts, methods, technologies,

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treatments, services, or preventative interventions that drive
this field will be changed if the proposed aims are achieved.
2. Innovation••

Explain how the application challenges current research or
clinical practice paradigms.
Describe any novel theoretical concepts, approaches or
methodologies, instrumentation or interventions to be
developed or used, and any advantage over existing
methodologies, instrumentation, or interventions.

3. Approach
•

•
•

•

•

Describe the overall strategy, methodology, and analyses tobe used to accomplish the specific aims of the project. Unlessaddressed separately in the Resource Sharing Plan, include
how the data will be collected, analyzed, and interpreted aswell as any resource sharing plans as appropriate.
Discuss potential problems, alternative strategies, andbenchmarks for success anticipated to achieve the aims.
If the project is in the early stages of development, describe
any strategy to establish feasibility, and address the
management of any high risk aspects of the proposed work.
Point out any procedures, situations, or materials that may behazardous to personnel and precautions to be exercised. A full
discussion on the use of select agents should appear in Item
18 below.
If research on Human Embryonic Stem Cells (hESCs) is
proposed but an approved cell line from the NIH hESC
Registry cannot be identified, provide a strong justification
for why an appropriate cell line cannot be chosen from theRegistry at this time.

If an applicant has multiple Specific Aims, then the applicant may address
Significance, Innovation and Approach for each Specific Aim
individually, or may address Significance, Innovation and Approach for
all of the Specific Aims collectively.
As applicable, also include the following information as part of the
Research Strategy, keeping within the three sections listed above:
Significance, Innovation, and Approach.
Preliminary Studies for New Applications: For new applications,
include information on Preliminary Studies. Discuss the PD/PI’s
preliminary studies, data, and or experience pertinent to this application.
Progress Report for Renewal and Revision Applications. For
renewal/revision applications, provide a Progress Report. Provide thebeginning and ending dates for the period covered since the lastcompetitive review. Summarize the specific aims of the previous project

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period and the importance of the findings, and emphasize the progress
made toward their achievement. Explain any significant changes to thespecific aims and any new directions including changes to the specificaims and any new directions including changes resulting from significant
budget reductions. A list of publications, patents, and other printed
materials should be included in the Progress Report Publication List; do
not include that information here.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

13. Progress Report
Publication List(for RENEWAL
applications only)

List the titles and complete references to all appropriate publications,
manuscripts accepted for publication, patents, and other printed materials
that have resulted from the project since it was last reviewed
competitively. When citing articles that fall under the Public AccessPolicy, were authored or co-authored by the applicant and arose from NIH
support, provide the NIH Manuscript Submission reference number (e.g.,
NIHMS97531) or the PubMed Central (PMC) reference number (e.g.,
PMCID234567) for each article. If the PMCID is not yet available
because the Journal submits articles directly to PMC on behalf of theirauthors, indicate “PMC Journal – In Process.” A list of these journals isposted at: http://publicaccess.nih.gov/submit_process_journals.htm.
Citations that are not covered by the Public Access Policy, but are
publicly available in a free, online format may include URLs or PubMed
ID (PMID) numbers along with the full reference (note that copies ofthese publications are not accepted as appendix material).
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

Human Subjects Sections
Field Name

Instructions

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14. Protection of Human
Subjects

Refer to Part II, Supplemental Instructions for Preparing the Human
Subjects Section of the Research Plan. Complete this section if you
answered “yes” to the question “are human subjects involved?” on the
R&R Other Project Information Form. If you answered “no” to thequestion but your proposed research involves human specimens and/or
data from subjects you must provide a justification in this section for yourclaim that no human subjects are involved.
Do not use the protection of human subjects section to circumvent thepage limits of the Research Strategy.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

15. Inclusion of Womenand Minorities

Refer to Part II, Supplemental Instructions for Preparing the Human
Subjects Section of the Research Plan. Complete this section if you
answered “yes” to the question “are human subjects involved?” on the
R&R Other Project Information Form and the research does not fall under
Exemption 4.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

16. Inclusion of Children

Refer to Part II Supplemental Instructions for Preparing the Human
Subjects Section of the Research Plan, Sections 4.4 and 5.7 Complete thissection if you answered “yes” to the question “are human subjects
involved?” on the R&R Other Project Information Form and the researchdoes not fall under Exemption 4.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

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Other Research Plan Sections
Field Name

Instructions

17. Vertebrate Animals

Complete this section if you answered “yes” to the question “areVertebrate Animals Used?” on the R&R Other Project Information Form.
If Vertebrate Animals are involved in the project, address each of the five
points below. This section should be a concise, complete description of
the animals and proposed procedures. While additional details may be
included in the Research Strategy, the responses to the five required
points below must be cohesive and include sufficient detail to allow
evaluation by peer reviewers and NIH staff. If all or part of the proposed
research involving vertebrate animals will take place at alternate sites(such as project/performance or collaborating site(s)), identify those sites
and describe the activities at those locations. Although no specific page
limitation applies to this section of the application, be succinct. Failure toaddress the following five points will result in the application being
designated as incomplete and will be grounds for the PHS to defer theapplication from the peer review round. Alternatively, the application’s
impact/priority score may be negatively affected.
If the involvement of animals is indefinite, provide an explanation andindicate when it is anticipated that animals will be used. If an award ismade, prior to the involvement of animals the grantee must submit to the
NIH awarding office detailed information as required in points 1-5 below
and verification of IACUC approval. If the grantee does not have an
Animal Welfare Assurance then an applicable Animal Welfare Assurance
will be required (See Supplemental Instructions Part III Section 2.2
Vertebrate Animals for more information).
The five points are as follows:1.

Provide a detailed description of the proposed use of the animals in
the work outlined in the Research Strategy section. Identify the
species, strains, ages, sex, and numbers of animals to be used in the
proposed work.

2.

Justify the use of animals, the choice of species, and the numbers to
be used. If animals are in short supply, costly, or to be used in large
numbers, provide an additional rationale for their selection andnumbers.

3.

Provide information on the veterinary care of the animals involved.

4.

Describe the procedures for ensuring that discomfort, distress, pain,
and injury will be limited to that which is unavoidable in the conductof scientifically sound research. Describe the use of analgesic,
anesthetic, and tranquilizing drugs and/or comfortable restraining
devices, where appropriate, to minimize discomfort, distress, pain,
and injury.

5.

Describe any method of euthanasia to be used and the reasons for its
selection. State whether this method is consistent with therecommendations of the American Veterinary Medical Association

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Instructions(AVMA) Guidelines on Euthanasia. If not, include a scientificjustification for not following the recommendations.
For additional information, see
http://grants.nih.gov/grants/olaw/VASchecklist.pdf
Do not use the vertebrate animal section to circumvent the page limits of
the research strategy.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.
For those applicants familiar with the PHS 398, please note that the
Literature Cited section of the Research Plan is now captured as“Bibliography & References Cited” in the Other Project InformationForm.

18. Select Agent Research

Select agents are hazardous biological agents and toxins that have been
identified by DHHS or USDA as having the potential to pose a severe
threat to public health and safety, to animal and plant health, or to animaland plant products. CDC maintains a list of these agents. See
http://www.cdc.gov/od/sap/docs/salist.pdf.
If the activities proposed in your application involve only the use of astrain(s) of select agents which has been excluded from the list of selectagents and toxins as per 42 CFR 73.4(f)(5), the select agent requirements
do not apply. Use this section to identify the strain(s) of the select agent
that will be used and note that it has been excluded from this list. The
CDC maintains a list of exclusions at
http://www.cdc.gov/od/sap/sap/exclusion.htm.
If the strain(s) is not currently excluded from the list of select agents andtoxins but you have applied or intend to apply to DHHS for an exclusionfrom the list, use this section to indicate the status of your request or yourintent to apply for an exclusion and provide a brief justification for the
exclusion.
If any of the activities proposed in your application involve the use of
select agents at any time during the proposed project period, either at theapplicant organization or at any other performance site, address thefollowing three points for each site at which select agent research willtake place. Although no specific page limitation applies to this section, be
succinct.
1.

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

2.

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

If the performance site(s) is a foreign institution, provide thename(s) of the country or countries where select agent research
will be performed.

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Instructions*An “entity” is defined in 42 CFR 73.1 as “any government
agency (Federal, State, or local), academic institution,
corporation, company, partnership, society, association, firm, sole
proprietorship, or other legal entity.”
3.

Provide a description of all facilities where the select agent(s) will beused.
•

Describe the procedures that will be used to monitor possession,use and transfer of the select agent(s).

•Describe plans for appropriate biosafety, biocontainment, andsecurity of the select agent(s).

•Describe the biocontainment resources available at all
performance sites.

If you are responding to a specific FOA, address any requirements
specified by the FOA.
Reviewers will assess the information provided in this Section, and anyquestions associated with select agent research will need to be addressed
prior to award.
Save this file in a location you remember. Click Add Attachment,
browse to where you saved the file, select the file, and then click Open.
19. Consortium/Contractual
Arrangements

Explain the programmatic, fiscal, and administrative arrangements to bemade between the applicant organization and the consortium
organization(s). If consortium/contractual activities represent a significant
portion of the overall project, explain why the applicant organization,rather than the ultimate performer of the activities, should be the grantee.
The signature of the Authorized Organization Representative on theSF424 (R&R) cover form signifies that the applicant and all proposed
consortium participants understand and agree to the following statement:
The appropriate programmatic and administrative personnel ofeach organization involved in this grant application are aware of
the agency’s consortium agreement policy and are prepared toestablish the necessary inter-organizational agreement(s)consistent with that policy.
A separate statement is no longer required.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

20. Resource Sharing
Plan(s)

NIH considers the sharing of unique research resources developed
through NIH-sponsored research an important means to enhance the value
and further the advancement of the research. When resources have beendeveloped with NIH funds and the associated research findings publishedor provided to NIH, it is important that they be made readily available forresearch purposes to qualified individuals within the scientificPart I: Instructions for Preparing and Submitting an Application

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community. See Supplemental Instructions Part III, 1.5 Sharing Research
Resources.
1. Data Sharing Plan: Investigators seeking $500,000 or more in direct
costs (exclusive of consortium F&A) in any year are expected to include abrief 1-paragraph description of how final research data will be shared, or
explain why data-sharing is not possible. Specific Funding Opportunity
Announcements may require that all applications include this information
regardless of the dollar level. Applicants are encouraged to read thespecific opportunity carefully and discuss their data-sharing plan with
their program contact at the time they negotiate an agreement with theInstitute/Center (IC) staff to accept assignment of their application. See
Data-Sharing Policy or http://grants.nih.gov/grants/guide/noticefiles/NOT-OD-03-032.html.
2. Sharing Model Organisms: Regardless of the amount requested, allapplications where the development of model organisms is anticipated are
expected to include a description of a specific plan for sharing anddistributing unique model organisms or state why such sharing is
restricted or not possible. See Sharing Model Organisms Policy, and NIH
Guide NOT-OD-04-042.
3. Genome Wide Association Studies (GWAS): Applicants seeking
funding for a genome-wide association study are expected to provide aplan for submission of GWAS data to the NIH-designated GWAS datarepository, or an appropriate explanation why submission to therepository is not possible. GWAS is defined as any study of genetic
variation across the entire genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight) or
the presence or absence of a disease or condition. For further information
see Policy for Sharing of Data Obtained in NIH Supported or Conducted
Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, andhttp://gwas.nih.gov/.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

21. Appendix

Do not use the appendix to circumvent the page limits of the Candidate
Information and the Research Strategy or any other section of theapplication for which a page limit applies. For additional information
regarding Appendix material and page limits, please refer to the NIH
Guide Notice NOT-OD-11-080, http://grants.nih.gov/grants/guide/noticefiles/NOT-OD-11-080.html.
Only one copy of appendix material is necessary. Use the Add
Attachments button to the right of this field to complete this entry.
Use the Add Attachments button to complete this entry. A maximum of
10 PDF attachments is allowed in the Appendix. If more than 10 appendix
attachments are needed, combine the remaining information into
attachment #10. Note that this is the total number of appendix items, notPart I: Instructions for Preparing and Submitting an Application

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the total number of publications. When allowed there is a limit of 3
publications that are not publicly available (see below for further details
and check the FOA for any specific instructions), though not all grantmechanisms allow publications to be included in the appendix.
Appendix material may not appear in the assembled application in theorder attached, so it is important to use filenames for attachments that aredescriptive of the content. A summary sheet listing all of the items
included in the appendix is also encouraged but not required. When
including a summary sheet, it should be included in the first appendix
attachment. Applications that do not follow the appendix requirements
may be delayed in the review process.
New, resubmission, renewal, and revision applications may include thefollowing materials in the Appendix:•

Publications – No longer allowed as appendix materials
except in the circumstances noted below. Applicants may
submit up to 3 of the following types of publications:•

Manuscripts and/or abstracts accepted for publication but not
yet published: The entire article should be submitted as a PDF
attachment.

•

Manuscripts and/or abstracts published, but a free, online,
publicly available journal link is not available: The entire
article should be submitted as a PDF attachment.

•

Patents directly relevant to the project: The entire document
should be submitted as a PDF attachment.

•

Do not include unpublished theses, or abstracts/manuscripts
submitted (but not yet accepted) for publication.)•

Surveys, questionnaires, and other data collection instruments;
clinical protocols and informed consent documents may besubmitted in the Appendix as necessary.

•

For materials that cannot be submitted electronically or materials
that cannot be converted to PDF format (e.g., medical devices,
prototypes, DVDs, CDs), applicants should contact the Scientific
Review Officer for instructions following notification of
assignment of the application to a study section. Applicants areencouraged to be as concise as possible and submit only
information essential for the review of the application.

Items that must not be included in the appendix:•

Photographs or color images of gels, micrographs, etc., are nolonger accepted as Appendix material. These images must be
included in the Research Plan PDF. However, images embedded
in publications are allowed.

•

Publications that are publicly accessible. For such publications,

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the URL or PMC submission identification numbers along withthe full reference should be included as appropriate in the
Bibliography and References cited section, the Progress Report
Publication List section, and/or the Biographical Sketch section.

3. CitizenshipOne selection is required. Please select the most appropriate response from the options provided. Other
than for the K99/R00 award program, the candidate must be a citizen or non-citizen national of the UnitedStates or its possessions and territories, or must have been lawfully admitted to the United States forpermanent residence by the time of award.
For those K award programs with a citizenship requirement, an individual who has applied for Permanent
Residence and expects to have obtained such status prior to the time award, may submit an application
recognizing that no award will be made until legal verification of permanent resident status is provided. If
a candidate’s citizenship status changes after submission of the application, the new status should bereported in the candidate’s Personal Profile in the eRA Commons. Before an award is issued, a permanent
resident will be required to submit a notarized statement that a licensed notary has seen the candidate’s
current and valid Permanent Resident Card or some other valid verification from the U.S. Immigration
and Naturalization Service of legal admission to the U.S. as a permanent resident.
It is the responsibility of the sponsoring institution to determine and retain documentation indicating thatthe individual candidate’s visa will allow him/her to reside in the proposed research training/careerdevelopment setting for the period of time necessary to complete the approved career development
program. Information may be requested by the NIH prior to issuance of an award.
Each candidate must check the applicable box, check only one:•

U.S. Citizen or non-citizen national: Check this box if the candidate is a U.S. Citizen or
Noncitizen national. Noncitizen nationals are people, who, although not citizens of the UnitedStates, owe permanent allegiance to the United States. They generally are people born in outlying
possessions of the United States (e.g., American Samoa and Swains Island).;•

Permanent Resident of U.S.: Check this box if the candidate has been lawfully admitted forpermanent residence; i.e., is in the possession of a current and valid Permanent Resident Card orother legal verification of such status. A notarized statement will be required as part of the preaward process.

•

Permanent Resident of U.S. Pending: Check this box if the candidate has applied for
Permanent Residence and expects to have obtained such status prior to the time of award. A
notarized statement will be required as part of the pre-award process.

•Non-U.S. citizen with temporary U.S. visa: This box is applicable only to specific programs
that do not require U.S. citizenship or permanent residency; e.g. K99/R00. The NIH awarding
component may request verifying information as part of the pre-award process.

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7.6 Career Development Award Peer Review Process
The goal of NIH-supported career development programs is to help ensure that diverse pools of highly
trained scientists are available in adequate numbers and in appropriate research areas to address the
Nation’s biomedical, behavioral, and clinical research needs. Each application must be tailored to theindividual candidate.
The general process information (Overview, Streamlining, and Dual-Level Peer Review) found in Part I.6
applies to K applications as well. However, the actual review criteria and other review considerations aredifferent. For K applications, the scientific review group will address individual career development
award applications by considering information provided for each of the following elements in theapplication:
Review Criteria:•

Candidate•

Career Development Plan/Career Goals & Objectives/Plan to Provide Mentoring•

Research Plan•

Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)•Environment and Institutional Commitment to the Candidate

Additional Review Criteria include the following;•

Protection of Human Subjects from Research Risk•

Inclusion of Women, Minorities, and Children in Research•Care and Use of Vertebrate Animals in Research•

Biohazards•

Resubmission Applications•

Renewal Applications (as applicable)

Additional Review Considerations include the following:•

Training in the Responsible Conduct of Research•

Select Agents•Resource Sharing Plans•

Budget and Period of Support

Candidates should carefully review the applicable FOA for complete information associated with the peer
review process. The FOA will describe essential information to be submitted for each of the above
elements.

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8.

Supplemental Instructions to the SF424 (R&R) for
Preparing Institutional Ruth L. Kirschstein
National Research Service Award (NRSA)
Application

8.1 Introduction
All applicants must use the SF 424 (R&R) Application for Federal Assistance, following the instructional
information in this section. The supplemental instructions found in this section (8) are for Institutional
National Ruth L. Kirschstein National Research Service Award (NRSA) applications and include
guidance and instructional information only when there is a difference in the required information to besubmitted or there is a need for more specificity for the institutional research training program. Therefore,
these supplemental instructions must be used along with the information found in Part I.1 – I.6 (seespecific training grant review process at the end of Section 8) of this document.
These instructions apply to NIH-supported NRSA institutional research training programs (e.g., T32, T34,
T35, T90). Some training programs are funded through Requests for Applications (RFAs) and may havespecial instructions.
Additionally, there are non-NRSA programs (e.g. T15, T37, D43, D71) which include research training
under different regulatory authorities, and, while some of the information may be the same, it is importantfor individuals interested in those programs to carefully read the applicable Funding Opportunity
Announcement (FOA) for specific program information and special application instructions. These
training programs may have different eligibility requirements, submission dates, award provisions, andreview criteria.
It is imperative that applicants become familiar with the NIH Research Training Activity code for which
support is being requested, and applicants should carefully review the applicable FOA which contains
more specific information associated with the award mechanism and the names of individuals that may becontacted for additional or clarifying information prior to submission of an application. Announcementsfor various training programs are issued periodically in the NIH Guide for Grants and Contracts, a weekly
publication (http://grants.nih.gov/grants/guide/index.html).
This section includes instructions to be used when applying for competing (New, Renewal, Resubmission
or Revision) institutional training grants, including both PHS Institutional Ruth L. Kirschstein National
Research Service Awards (Kirschstein-NRSA) and non-NRSA awards. The contents include substituteboth budget pages, and instructions for the Research Training Program Plan. Begin by reading theprevious Sections 4 and 5, and then follow both sets of instructions.
Prior to preparing an application, review the Funding Opportunity Announcement (FOA) to which you
are responding and consult with the appropriate PHS awarding component identified in the FOA. Current
NIH-wide T32, T34 or T35 Kirschstein-NRSA Program Announcements (PA) are available at(http://grants.nih.gov/training/nrsa.htm). Note especially the eligibility requirements, submission dates,
review criteria, award provisions, and payback provisions (when applicable). PAs are also issued
periodically by the individual NIH Institutes or Centers in the NIH Guide for Grants and Contracts. This
information is available from the appropriate PHS agency, from grantee offices of sponsored programs, or
equivalent offices.
Please note that for Kirschstein-NRSA programs that include postdoctoral trainees, the Program Director
must explain the terms of the payback service requirement to all prospective postdoctoral training

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candidates. A complete description of the service payback obligation is available in the relevant NRSA
Program Announcement or the NIH Grants Policy Statement.

8.2 Institutional Research Training Programs
Prospective applicants are encouraged to review the T Kiosk for the most current program information.
The T Kiosk includes information on NIH-wide Parent FOAs as well as IC-specific FOAs for a particular
T programs. In addition, non-NRSA training programs are described here:
http://grants.nih.gov/training/F_files_non_nrsa.htm.

8.3 Reserved
8.4 Specific Instructions for Institutional Training Grant
Applications using the SF424 (R&R) Application
Standard instructions found in Parts I.1 – I.6 should be followed with the exceptions found in this section.
Section numbers referenced below (e.g. 4.2 - 5.6) reflect those found in Part I.

8.4.1 Special Instructions for 4.2 Cover Form
Proposed Project Start and Ending Dates
The usual starting date for an institutional Kirschstein-NRSA is July 1, but there are other possible
starting dates. Consult the webpage of Standard Due Dates for Competing Applications(http://grants.nih.gov/grants/funding/submissionschedule.htm). Many PHS awarding components restrict
submission and review dates to once a year. Applicants are strongly encouraged to contact the appropriate
awarding component staff before submitting an application.

8.4.2 Special Instructions for 4.3 Research & Related
Project/Performance Site Locations
List all of the locations where training, program management, and the research training experiences
described in the Research Training Program Plan (8.7) will be performed. If a Project/Performance Site
will be engaged in research involving human subjects, it is the responsibility of the applicant organization
to assure that all Project/Performance Sites comply with the human subject protection regulations in 45
CFR part 46 and NIH policies for the protection of human subjects. For research involving live vertebrate
animals, the applicant organization must supply information for all training sites where animals will be
used by trainees. The applicant organization is responsible for assuring that all Project/Performance Sites
have a current Animal Welfare Assurance and comply with the PHS Policy on Humane Care and Use ofLaboratory Animals.

8.4.3 Special Instructions for 4.4 Research & Related Other Project
Information FormAre Human Subjects Involved?
Check “Yes” if training plans include or potentially will include involvement of trainees in projects that
include human subjects as defined by 45 CFR 46. Check “Yes” even if the proposed project is exempt

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from Regulations for the Protection of Human Subjects. If no activities involving human subjects areplanned, check the No box, and skip the rest of this block. This field is required.
The institution must ensure that trainees who will be involved in the design or conduct of research
involving human subjects receive training in human subjects protections. It is the institution’s
responsibility to ensure that trainees are properly supervised when working with human subjects.
In many instances, trainees supported by institutional training grants will be participating in researchsupported by research project grants for which the IRB approval or a determination of exemption exists.
Existing IRB approval is sufficient for trainees, provided that the IRB determines the research would not
be substantially modified by the participation of a trainee. The appropriate grants must be identified alongwith their IRB approval dates or exemption designation in Section 7 of the Research Training Program
Plan.
Note that IRB approval information for the full training grant application is not required at the time ofsubmission, but will be requested as Just-in-time (JIT) information prior to award. If an award is madeand the research is not exempt from requirements stipulated in 45 CFR 46, and trainees will participate inresearch for which IRB review and approval does not otherwise exist, human subjects may not be
involved and trainees may not participate in research involving human subjects unless the engaged
institution has an approved FWA on file with OHRP, certification of the date of IRB approval has been
submitted to and accepted by the PHS agency, and NIH requirements for human subjects protections havebeen addressed (see instructions in Part II, Supplemental Instructions for Preparing the Human Subjects
Section of the Research Plan, and the NIH Grants Policy Statement(http://grants.nih.gov/grants/policy/nihgps_2012/index.htm)).
These policies apply to all Performance Sites.
Are Vertebrate Animals Used?
Check “Yes” if training plans include or potentially will include trainees in projects involving the use oflive vertebrate animals at any time during the proposed project period.
Otherwise, check “No”, and skip the rest of this block. This field is required.
In many instances, trainees supported by institutional training grants will be participating in researchsupported by research project grants for which the IACUC review and approval exists. This existing
IACUC approval is sufficient for trainees, provided that the research would not be substantially modified
by the participation of a trainee. The appropriate grants must be identified along with their IACUC
approval dates in Section 8 of the Research Training Program Plan.
Note that vertebrate animal approval information for the full training grant application is not required at
the time of submission, but will be requested as Just-in-time (JIT) information prior to award. If an award
is made and trainees will participate in research for which IACUC approval does not otherwise exist,
vertebrate animals may not be involved and trainees may not participate in research utilizing vertebrate
animals unless the institution has an OLAW-approved Animal Welfare Assurance, certification of thedate of IACUC approval has been submitted to and accepted by the PHS agency, and NIH requirements
for the use of vertebrate animals have been addressed.
The institution must ensure that trainees are enrolled in the institution's animal welfare training andoccupational health and safety programs for personnel who have contact with animals. It is theinstitution's responsibility to ensure that trainees are properly supervised when working with live
vertebrate animals.
These policies apply to all Performance Sites.

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Project Summary/Abstract
Summarize the objectives, rationale and design of the research training program. Provide information
regarding the research areas and scientific disciplines encompassed by the program. Include a brief
description of the level(s) (i.e., undergraduate, predoctoral, postdoctoral, faculty) and duration of the
proposed training, the projected number of participating trainees and their anticipated levels of
experience. This section must be no longer than 30 lines of text and must follow the required font andmargin specifications.
Project Narrative
Using no more than two or three sentences, describe the relevance of this research training program to
public health. In this section, use plain language that can be understood by a general, lay audience.
Bibliography & References Cited
This item should be used only to cite references supporting the need, rationale, and approach for the
training program described in the PHS 398 Research Training Program Plan. Note that the Literature
Cited section of the Research Plan is captured in this section (unlike the placement in the PHS 398). Do
not include lists of publications of project directors, mentors or trainees in this section, as this information
will be included in the biosketches and Data Tables.
Facilities & Other Resources
Describe the facilities and resources that will be used in the proposed training program. Indicate in whatways the applicant organization will support the program, financial or otherwise (e.g., supplementation of
stipends, protected time for mentoring, support for student activities). This could also include, forexample, space, shared laboratory facilities and equipment, funds for curriculum development, releasetime for the PD/PI and participating faculty, support for additional trainees in the program, or any othercreative ways to improve the climate for the establishment and growth of the research training program.
Other Attachments
Leave blank, unless specifically requested in the FOA.

8.4.4 Special Instructions for 4.5 Senior/Key Person Profile(Expanded) Form
Complete the Profile for the Program Director according to instructions in Section 4.5.
If multiple PD/PIs are proposed, explain in the Program Plan your rationale for how this will facilitate
program administration. If your application involves Multiple PD/PIs, follow the directions in Section 4.5
to designate the Contact PI and to assign the PD/PI role to other senior/key persons. Additionally, theapplication must include a Multi-PD/PI Leadership Plan emphasizing how it will benefit the program andthe trainees. Do not submit a leadership plan if you are not submitting a Multiple PD/PI application. See
Part I Section 8.7 for information associated with Multiple Program Directors.
Complete the profiles for other senior/key persons according to instructions in Section 4.5.
The Program Director(s) (in case of multiple PD/PIs), training faculty and any other individuals whose
contributions are critical to the development, management and execution of the Research Training
Program Plan in a substantive, measurable way (whether or not salaries are reimbursed) should be
identified as senior/key persons. These would include co-Director(s), if applicable, and program staff.
Since these efforts are not project related research endeavors, they should not be identified in Other
Support information. Do not include proposed mentors and training faculty members (other thanPart I: Instructions for Preparing and Submitting an Application

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senior/key persons) in this section. Biographical Sketches for mentors and participating faculty will be
included in the PHS 398 Research Training Program Plan Form, Participating Faculty Biosketches.

8.4.5 Special Instructions for 4.7 Research & Related Budget
This form is required for use in conjunction with the PHS 398 Training Budget for the R90 portion of
T90/R90 applications, and is the only budget form that should be used for K12 applications. Otherwise
this form should only be used when allowed or required in an FOA or IC-specific notice orannouncement. Follow instructions in Section 4.7.

8.4.6 Special Instructions for 4.6 PHS 398 Cover Page Supplement
Human Subjects
If you checked “Yes” to Human Subjects and “Yes” to Clinical Trial on the R&R Other Project
Information form, you must check either “Yes” or “No” to indicate whether plans include or potentially
include trainee participation in projects that are NIH-Defined Phase III Clinical Trials.
Inventions and Patents
Not applicable – leave blank.
Program Income
Check “No”.
Human Embryonic Stem Cells (hESC)
Check “Yes” if training plans include or potentially will include involvement of trainees in projects that
include human embryonic stem cells.
If “Yes”, list the 4-digit NIH Registration Number of the specific cell line(s) from the NIH Human
Embryonic Cell Registry, or check the box indicating that the specific stem cell line cannot be referenced
at this time. Applications proposing the use of hESC must either specify a cell line(s) from the NIH Stem
Cell Registry that will be used in the proposed research or, provide a strong justification for why anappropriate cell line cannot be chosen from the Registry at the time of application and a certification that
one from the Registry will be used. The justification should be included in the Research Strategy sectionof the application. For additional guidance, see NIH Guide Notice NOT-OD-12-111 Notice of Impending
Change in Peer Review Criteria and Submission Requirements for NIH Applications Involving Human
Embryonic Stem Cells.
Note that individual project HESC information is not required at the time of application, but will be
requested as Just-in-time (JIT) information prior to award. At that time, the NIH will require information
regarding project title, mentor and specific cell line(s) from the registry(http://grants.nih.gov/stem_cells/registry/current.htm) for each trainee utilizing human embryonic stem
cells in a research project. Trainees may not participate in human embryonic stem cell related research
until this information is provided.

8.5 PHS 398 Training Budget
For NRSA training grant programs, use the PHS 398 Training Budget form pages and follow the
instructions below. Refer to the relevant FOA or consult the PHS awarding component for current stipend
levels and allowable costs.

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For Non-NRSA training grant programs refer to the FOA for instructions regarding which Budget Formpages to use and how to complete them.

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If you are requesting a budget of $500,000 direct costs or more for any year, contact the awarding
component to determine whether you must obtain prior approval before submitting the application. Some
Institutes/Centers do not require prior approval. (See Policy on the Acceptance for Review of Unsolicited
Applications That Request $500,000 or More in Direct Costs.)
PHS 398 Training Budget, Periods 1 through 5Part A. Stipends, Tuition/FeesEnter the number of trainees, total stipend amount and total tuition/fees for each trainee category as
appropriate. Use the current Institutional Kirschstein-NRSA stipend schedule,(http://grants.nih.gov/training/nrsa.htm). If a category contains different stipend levels, e.g., for varying
levels of postdoctoral experience and/or varying appointment periods, itemize in the appropriate blocks.
Enter the total stipends for all categories.
See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-073.html for NIH policy regarding
payment of tuition and fees. Tuition at the postdoctoral level is limited to that required for specified
courses that are to be described in the Budget Justification (Part F.). Tuition and fees may be requested
only to the extent that the same resident or nonresident tuition and fees are charged to regular nonFederally supported students and postdoctoral fellows. Where applicable, trainees should be divided into
non-degree-seeking and degree-seeking categories. Note that health insurance is not included as part ofthis budget category. See the Training Related Expenses category below. Grantees should request fullneeds. The formula currently in effect will be applied by the NIH awarding component at the time anaward is calculated.
Part B. Other Direct Costs
Enter the total costs for Trainee Travel, Training Related Expenses, Total Direct Costs from R&R Budget
Form (if applicable) and Consortium Training Costs (if applicable).
Trainee Travel
Some NIH awarding components pay a flat rate per trainee for trainee travel for all long-term trainees.
See the appropriate FOA and/or contact the awarding component to determine the amount provided fortravel. In the budget justification, state the purpose of any travel, giving the number of trips involved, thedestinations, and the number of trainees for whom funds are requested. PHS policy requires coach class
air travel be used. Justify foreign travel in detail, describing its importance to the training experience.
Enter the total amount requested in the Trainee Travel column.
Training Related Expenses (TRE)
Funds to defray other costs of training, such as health insurance (self-only or family), staff salaries,
consultant costs, equipment, research supplies, staff travel, etc., are requested as a lump sum based on theamounts specified in the FOA and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-10-073.html
for each predoctoral and postdoctoral trainee. Based on the number of trainees at the predetermined rate,
enter the total dollar figure.
Health insurance (self-only or family, as applicable) is an allowable cost that may be requested as part oftraining related expenses, but only to the extent that the same health insurance fees are charged to regular
non-Federally-supported students and postdoctoral fellows. The allowable TRE amount will be awarded
as a lump sum. No further itemization or explanation is required.
The awarding Institute/Center will apply the Training Related Expenses level established for NRSA
Institutional programs for the relevant fiscal year at the time of award.

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Total Direct Costs from R&R Budget Form (if applicable)
Certain FOAs allow funds to cover costs for items other than those specified above. Use Research &Related Budget Pages, Sections A through I and K, to submit those costs. Total Direct Costs from the
Research & Related Budget page should be inserted here. This line should not include any applicant
indirect costs.
Consortium Training Costs (if applicable)
If training is occurring at more than one institution, and any transfer of funds between institutions occurs,
the Training Subaward Budget Attachment Form should be used. (See Section 4.8). Total the direct costs
from the Subaward Budget Attachment Forms and insert here. The applicant institution is responsible andaccountable for any arrangements, expenditures, and submission of all required forms when more than
one institution is involved in the research training program.
Part C. Total Direct Costs Requested
Total dollar amount of other direct costs requested (automatically calculated).
Part D. Indirect Costs
Facilities and Administrative (F&A) costs under Institutional Kirschstein-NRSAs, other than those issued
to U.S., state, or local government agencies, will be awarded at 8%, excluding tuition/fees, equipment,
and sub-grants and contracts in excess of $25,000. Equipment and consortium costs are also excluded
from the F&A costs on those training grants where Training Related Expenses are not calculated andawarded on a lump-sum basis, such as the Minority Access to Research Careers Program (MARC) or
Career Opportunities in Research (COR) Undergraduate Research Training Program. State and local
government agencies will receive the full F&A cost rate.
Indirect Cost Type: Enter “F&A”
Indirect Cost Rate (%): Enter “8”Indirect Cost Base ($): Enter the sum of Stipends and Total Other Direct Costs requested, regardless ofwhether those direct costs were listed on the PHS 398 Training Budget page or Research & Related
Budget page. Indirect costs are not paid on Tuition/Fees, equipment, and sub-grants and contracts inexcess of $25,000.
Funds Requested ($): Enter the product of Indirect Cost Rate multiplied by Indirect Cost Base.
Part E. Total Direct and Indirect Costs Requested (C+D)
The sum of Total Direct Costs Requested and Total Indirect Costs Requested will be calculated
automatically.
Part F. Budget Justification
A detailed justification is to be attached only for the first budget period, but should reflect the entire
budget period. Explain in detail the composition of any of the above items, as necessary. Itemize tuition
and individual fees. If tuition varies, (e.g., in-state, out-of-state, student status) identify these separately. If
tuition is requested for postdoctoral trainees, the specific courses must be described in the application. If
trainee travel is not paid at a flat rate per trainee by the awarding component, state the purpose of any
travel, giving the number of trips involved, the destinations, and the number of individuals for whomfunds are requested, bearing in mind that PHS policy requires coach class air travel be used. For
postdoctoral training slots, justify the stipend levels requested.
Any foreign travel must be justified in detail, describing its importance to the training experience andconsidering the type of opportunities available for training, how those opportunities differ from andPart I: Instructions for Preparing and Submitting an Application

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complement those offered by the grantee institution, and the relationship of the proposed off-site training
experience to the career stage of the grantee.
This budget justification should apply only to funds requested on the PHS 398 Training Budget form.
When the Research & Related Budget Form is also used, two separate budget justifications are required,each covering the costs required in the particular budget form. Combining the information into a single
upload is acceptable; however, each budget form requires a budget justification attachment so the samebudget justification will need to be included in both budget forms.
PHS 398 Training Budget, Cumulative Budget
All values on this form are calculated automatically. They present the summations of the amounts thatyou have entered previously, for each of the individual budget periods. Therefore, no data entry isallowed or required.
If any of the amounts displayed on this form appears to be incorrect, you may correct it by adjusting one
or more of the values that contribute to that total. To make any such adjustments, you will need to revisit
the appropriate budget period form(s) to enter corrected values.

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8.6 PHS 398 Training Subaward Budget Attachment(s) Form

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This form should be used when proposing subawards to other institutions. Complete the Subaward
Budget for each contractor or collaborating institution. For NRSA programs, this is not common but is
usually encountered when a portion of the training program takes place at a site other than the grantee
institution via a collaborative or consortium arrangement. In such situations, the grantee institution is
responsible and accountable for acceptable training arrangements, expenditure of funds and thesubmission of all required forms.
This form accommodates up to 30 separate subaward budgets. If you are submitting an application with
>30 subaward budgets, budgets 31 and above should be converted to PDF and included as part of Section
8.5 Part F. Budget Justification, of the parent budget (PHS 398 Training Budget). Reminder, the sum of
all subaward budgets; e.g., those attached separately and those provided as part of the budget justification,must be included in Part B. Consortium Training Costs on the PHS 398 Training Budget.
To start the process, the applicant organization should:•

Select the Subaward Budget Attachment Form from the Optional Documents in the Grant
Application Package.

•

Open the form, and click the “Select to Extract a Training Subaward Budget Attachment”
button in the middle of the form. A “SAVE” dialog box appears.

•

Save the file locally using the first ten letters of the consortium organization’s name and use“.pdf” as the file extension. (The extracted file is an Adobe PDF file.) Once you have saved thefile there is no need to extract another budget attachment. Doing so may cause you to lose any
data already stored in the saved file.

•E-mail the extracted, saved form to the consortium grantee. Note: consortium grantees must haveinstalled Adobe Reader before they can complete the form. The consortium grantee should
complete all the budget information as instructed in the R&R Budget form instructions in Section
4.7. Note: Organizational DUNS and Name of Organization fields must reflect that of thesubaward/consortium grantee.

•

The consortium grantee must complete the budget form and e-mail it back to the applicant
organization.

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Return to the Subaward Budget Attachment Form and attach the consortium grantee’s budget toone of the blocks provided on the form.

Submitting Subaward Budgets that are not Active for all Periods of the Prime Grant
When submitting subaward budgets that are not active for all periods of the prime grant, fill out thesubaward R&R Budget form and include only the number of periods for which the subaward is active.
The budget period start/end dates reflected in each period should reflect the corresponding prime budget
period start/end dates. This approach is the most workable solution to the limitations in existing forms
that do not allow an “empty” budget period and do not allow submission of a subaward budget with zeroeffort to skip a budget period.
For example, suppose the prime has filled out a budget form with the following periods:•

period 1 Jan 1, 2010 – Dec 31, 2010•

period 2 Jan 1, 2011 – Dec 31, 2011•

period 3 Jan 1, 2012 – Dec 31, 2012•

period 4 Jan 1, 2013 – Dec 31, 2013•

period 5 Jan 1, 2014 – Dec 31, 2014

Now, suppose there is a subaward that performs in support year 1 and does not become active again until
support year 4. The subaward can fill out the first two periods of their budget form as follows:•

period 1 Jan 1, 2010 – Dec 31, 2010 (dates correspond to prime period 1)•

period 2 Jan 1, 2013 – Dec 31, 2013 (dates correspond to prime period 4)

It is not necessary that the budget period numbers between the prime and subaward match; the correlationis reflected in the dates. Do be careful, however, that the dates exactly match what is listed for the period
in the prime budget.
Note this approach may cause a validation warning regarding the NIH $500,000 per year limit on direct
costs, therefore you should document in both the cover letter and the subaward budget justification thatthe subaward is only active for specific periods of the prime. Appropriate NIH staff has access to thecover letter and reviewers have access to the budget justification. This documentation will make the datecorrelation immediately apparent and will help avoid any confusion.

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8.7 Research Training Program Plan Form

Before preparing the Research Training Program Plan, be sure to check the specific instructions in
the Funding Opportunity Announcement (FOA) to which you are responding. Contact theappropriate PHS awarding component, which may have further advice or suggestions oncompleting your application, including the data tables mentioned below.
Note that there are page limits for certain sections. Follow the page limits for the Institutional ResearchTraining and Career Development Applicants, Including Ruth L. Kirschstein NRSA Application in thetable of page limits (Table 2.6-1), unless specified otherwise in the FOA. Please see NOT-OD-11-039 and
NOT-OD-11-076. The information provided in required data tables (see below) will not be counted
toward the page limitation. These tables should be numbered consecutively and titled as shown, even if
some are not required by the PHS awarding component to which you are applying or in the FOA to which
you are responding. Indicate by table number and title, those tables that are intentionally omitted.
Additional tables that are not required may be included in the Research Training Program Plan, however,these tables will count as part of the page limit. Additional tables not specified in these instructions

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should be identified by letter, rather than number to avoid confusion with the sequentially numberedrequired tables.
The instructions for Data Tables 1-12 are located on the OER website at http://grants.nih.gov/grants/
funding/424/index.htm#datatables. Please read the Introduction to the Data Tables before beginning toprepare your application. This section includes important definitions that should be used consistently bothin the Data Tables and in all other parts of the application. The data tables should be included in theapplication at the point indicated and should not be inserted in the narrative.
The Research Training Program Plan should include sufficient information needed for evaluation of the
program, independent of any other document (e.g., previous application). Be specific and informative,
and avoid redundancies.
Research Training Program Plan Attachments(See also Section 2.3.2 Creating PDFs for Text Attachments.)
Although many of the sections of this application are separate PDF attachments, page limitations
referenced in the instructions and/or funding opportunity announcement must still be followed. Agency
validations will include checks for page limits (and use of appropriate font). Some accommodation will bemade for sections that, when combined, must fit within a specified limitation.
Text attachments should be generated using word processing software and then converted to PDF using
PDF generating software. Avoid scanning text attachments to convert to PDF since that causes problems
for the agency handling the application. In addition, be sure to save files with descriptive file names.
Do not include any information in a header or footer of the attachments. A header will be systemgenerated that references the name of the PD/PI. Page numbers for the footer will be system-generated in
the complete application, with all pages sequentially numbered.
Since a number of reviewers will be reviewing applications as an electronic document and not a paper
version, applicants are strongly encouraged to use only a standard, single-column format for the text.
Avoid using a two-column format since it can cause difficulties when reviewing the document
electronically.
Full-sized glossy photographs must only be included within the page limitations of the Research Training
Plan. The maximum size of images to be included should be approximately 1200 x 1500 pixels using 256
colors. Figures must be readable as printed on an 8.5 x 11 inch page at normal (100%) scale.
Investigators must use image compression such as JPEG or PNG. Do not include figures or photographs
as separate attachments either in the Appendix or elsewhere in the application.
Separate Attachments
Separate attachments have been designed for the Research Training Program Plan sections to maximize
automatic validations conducted by the eRA system. When the application is received by the agency, allof the Research Training Program Plan sections will be concatenated in the appropriate order so that
reviewers and agency staff will see a single cohesive Research Plan.
When attaching a PDF document to the actual forms, please note you are attaching an actual document,
not just pointing to the location of an externally stored document. Therefore, if you revise the document
after it has been attached, you must delete the previous attachment and then reattach the revised document
to the application form. Use the “View Attachment” button to determine if the correct version has been
attached.
Follow page limitations as specified in Funding Opportunity Announcements.

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All applications and proposals for NIH funding must be self-contained within specified page limitations.
Agency validations will include checks for page limits. Note that while these computer validations will
help minimize incomplete and/or non-compliant applications, they do not replace the validations
conducted by NIH staff. Applications found not to comply with the requirements may be delayed in thereview process. Unless otherwise specified in an NIH solicitation, internet website addresses (URLs) may
not be used to provide information necessary to the review because reviewers are under no obligation toview the internet sites. Moreover, reviewers are cautioned that they should not directly access an internet
site as it could compromise their anonymity.
Notice of Proprietary Information
Applicants are discouraged from submitting information considered proprietary unless it is deemed
essential for proper evaluation of the application. However, when the application contains informationthat constitutes trade secrets, or information that is commercial or financial, or information that isconfidential or privileged, make sure you have checked “Yes” in the “Other Project Information” form.
When information in the application constitutes trade secrets or information that is commercial or
financial, or information that is confidential or privileged, it is furnished to the Government in confidencewith the understanding that the information shall be used or disclosed only for evaluation of thisapplication. However, if a grant is awarded as a result of or in connection with the submission of thisapplication, the Government shall have the right to use or disclose the information to the extent
authorized by law. This restriction does not limit the Government’s right to use the information if it isobtained without restriction from another source.
Although the grantee institution and the PD/PI will be consulted about any such release, the PHS will
make the final determination. Any indication by the applicant that the application contains proprietary or
privileged information does not automatically shield the information from release in response to a
Freedom of Information Act (FOIA) request should the application result in an award (see 45 CFR Part5). If an applicant fails to identify proprietary information at the time of submission as instructed in theapplication guide, a significant substantive justification will be required to withhold the information if
requested under FOIA.
Begin each text section of the Research Training Program Plan with a section header (e.g.,
Introduction, Background, Program Plan, etc).
Field Name

Instructions

1. Introduction to
Application (forResubmission or Revision
only)

Use only if Type of Application is Resubmission or Revision The
Introduction may not exceed 3 pages for resubmissions (previously known
as a revision or amendment) or 1 page for revisions (previously known ascompeting supplements). See specific instructions in Section 2.7“Resubmission” Applications and 2.8 “Revision” Applications concerning
the content of the Introduction.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

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Field Name

Instructions

2. Background

The Background must fit within the page limits for Institutional ResearchTraining and Career Development Applicants, Including Ruth L.
Kirschstein NRSA Application in the table of page limits (Table 2.6-1),
unless specified otherwise in the FOA. Please see NOT-OD-11-039 and
NOT-OD-11-076.
Provide the rationale for the proposed research training program, relevant
background history, and the need for the research training proposed.
Indicate how the proposed program relates to current training activities at
the applicant institution.
Summarize the research training activities of the major participating
unit(s) and department(s) represented in the proposed program. Complete
and refer to the data reported in Tables 1-3:
Table 1. Membership of Participating Departments/Programs
Table 2. Participating Faculty Members
Table 3. Institutional Training Grant Support Available to Participating
Faculty Members, Departments, or Programs
Use this data to document the environment in which the proposed training
program will take place.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

3. Program Plan

The Program Plan must fit within the page limit for Institutional ResearchTraining and Career Development Applicants, Including Ruth L.
Kirschstein NRSA Application in the table of page limits (Table 2.6-1),
unless specified otherwise in the FOA.
Please see NOT-OD-11-039 and NOT-OD-11-076.
a. Program Administration. Describe the Program Director'squalifications for providing leadership of the program, including relevantscientific background, current research areas, and experience in researchtraining. Indicate the Program Director's percent effort in the proposed
program.
Describe the administrative structure of the program and the distribution of
responsibilities within it, including the means by which the program
director will obtain continuing advice with respect to the operation of the
program.
If multiple PD/PIs are proposed, explain in this section your rationale for
how this will facilitate program administration. In addition, you mustcomplete the Multiple PD/PI Leadership Plan.
b. Program Faculty. Refer to the data presented in Table 2. Participating
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Field Name

Instructions
member's research that is relevant to the program and indicate how
trainees will participate in the research. Describe the extent to which
participating faculty members cooperated, interacted, and collaborated in
the past, including joint publications and joint sponsorship of student
research. Complete and refer to data in Tables 4-6:
Table 4. Grant and Contract Support of the Participating Faculty Members
Table 5. Pre and Postdoctoral Trainees of Participating Faculty Members
Table 6. Publications of Research Completed by Trainees (or Potential
Trainees)
Use these tables to document the ability of the faculty to support the
research activities of the proposed trainees, the training record of thefaculty members, and the success of their trainees in generating
publishable research results.
For new applications, see the instructions for Table 6A or 6B, asapplicable, and list publications for trainees who are representative of
those who would be appointed if the grant is awarded. For Renewal
applications, this data constitutes part of the Progress Report (see Progress
Report below).
c. Proposed Training. Describe the proposed training program. State thetraining level and number of trainees. For postdoctoral trainees, indicate
the proposed distribution by degree (e.g., M.D., Ph.D.). Describe course
work and research opportunities, the extent to which trainees will
participate directly in research, and the duration of training, i.e., usual
period of time required to complete the training offered.
Indicate how the individual disciplinary and/or departmental componentsof the program are integrated and coordinated and how they will relate to
an individual trainee's experience.
For training programs that emphasize research training for clinicians,
describe the interactions with basic science departments and scientists.
Include plans for ensuring that the training of these individuals will
provide a substantive foundation for a competitive research career.
Generally, a minimum of 2 years of research training is required for all
postdoctoral trainees with health professional degrees. Describe fully any
trainee’s access to and responsibility for patients, including timecommitment.
Provide representative examples of programs for individual trainees.
Include curricula, degree requirements, didactic courses, laboratory
experiences, qualifying examinations, and other training activities, such as
seminars, journal clubs, etc. Describe how the preceptor and research
problems are chosen, how each trainee's program will be guided, and how
the trainee's performance will be monitored and evaluated. Include
detailed mentoring plans as appropriate.
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provide a strong justification for why an appropriate cell line cannot bechosen from the Registry at this timed. Training Program Evaluation. Describe an evaluation plan to review
and determine the quality and effectiveness of the training program. Thisshould include plans to obtain feedback from current and former trainees
to help identify weaknesses in the training program and to provide
suggestions for program improvements. In addition, describe plans forassessing trainee’s career development and progression, including
publications, degree completion, and post-training positions. Evaluation
results are to be included in renewal (competing continuation) applications
and as part of the Final Progress Report.
e. Trainee Candidates. Describe recruitment plans, including the sources
and availability of trainees; the qualifications of prospective trainees; andthe criteria and procedures by which trainees will be selected.
f. Institutional Environment and Commitment to Training. The
administration of the applicant institution as well as all participating units
and departments should include information in the application that
documents institutional support and commitment to the goals of theresearch training program. The application should include a description of
support (financial and otherwise) to be provided to the proposed program.
This could include, for example, space, shared laboratory facilities andequipment, funds for curriculum development, release time for the PD/PI
and/or participating faculty, support for additional trainees in the program,or any other creative ways to improve the climate for the establishment
and growth of the research training program.
Admissions and Completion Records
For programs that request only predoctoral trainee support, complete Table
7A. Admissions and Completion Records for the Participating
Departments and Programs During the Past Five Years (Predoctoral
Applicants).
For programs that request only postdoctoral trainee support, complete
Table 7B. Admissions and Completion Records for the Participating
Departments and Programs During the Past Five Years (Postdoctoral
Applicants).
Programs requesting support for both predoctoral and postdoctoral trainees
need to complete both Table 7A and Table 7B. Applicant institutions do
not need to submit pre-enrollment data for individuals with disabilities andindividuals from disadvantaged backgrounds in the first two data columnsof these tables. However, all other information requested in the Table 7A
and Table 7B must be provided as instructed.
Use these tables to document the ability of the participating
departments/programs to recruit and retain predoctoral and/or postdoctoral
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recruitment and retention of trainees from diverse backgrounds, and to
defend the requested number of training positions to be awarded.
Qualifications of Applicants
For programs that request only predoctoral trainee support, complete Table
8A. Qualifications of Recent Predoctoral Applicants.
For programs that request only postdoctoral trainee support, complete
Table 8B. Qualifications of Recent Postdoctoral Applicants.
Programs requesting support for both predoctoral and postdoctoral trainees
need to complete both Table 8A and Table 8B.
Use these tables to document the quality and depth of the applicant pools,
including both Kirschstein-NRSA training grant eligible and nonKirschstein-NRSA eligible applicants; the selectivity of the admissions
process; the competitiveness of the program; and to justify the number of
number of training positions requested.
Current Trainee Qualifications
For programs that request only predoctoral trainee support, complete Table
9A. Qualifications of the Current Predoctoral Trainees Clearly Associatedwith the Training Program.
For programs that request only postdoctoral trainee support, complete
Table 9B. Qualifications of the Current Postdoctoral Trainees Clearly
Associated with the Training Program.
Programs that request both predoctoral and postdoctoral trainee support
need to complete both Table 9A and Table 9B.
Use these tables to document the number and quality of all trainees
currently enrolled in the program, and their distribution by department andmentor; the selectivity of enrollment appointments to the training grantover the time period represented by the current program participants; andto defend the number of training positions to be awarded.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

4. Recruitment andRetention Plan to Enhance
Diversity

This section must fit within the combined 25-page limit for sections 2.22.4. Please see NOT-OD-11-039 and NOT-OD-11-076.
A Recruitment and Retention Plan to Enhance Diversity is required for all
training grant activity codes except T34, T36, U2R, and all D-series
activity codes.
The NIH recognizes a unique and compelling need to promote diversity inthe biomedical, behavioral, clinical and social sciences workforce. The
NIH expects efforts to diversify the workforce to lead to the recruitment ofPart I: Instructions for Preparing and Submitting an Application

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the most talented researchers from all groups; to improve the quality of theeducational and training environment; to balance and broaden theperspective in setting research priorities; to improve the ability to recruit
subjects from diverse backgrounds into clinical research protocols; and to
improve the Nation’s capacity to address and eliminate health disparities.
Accordingly the NIH continues to encourage institutions to diversify theirstudent and faculty populations and thus to increase the participation ofindividuals currently underrepresented in the biomedical, clinical,
behavioral, and social sciences such as: individuals from underrepresented
racial and ethnic groups, individuals with disabilities, and individuals fromsocially, culturally, economically, or educationally disadvantaged
backgrounds that have inhibited their ability to pursue a career in healthrelated research. Institutions are encouraged to identify candidates whowill increase diversity on a national or institutional basis.
Definition of Diversity Recruitment Groups
The NIH is particularly interested in encouraging the recruitment andretention of the following classes of candidates:A.

Individuals from racial and ethnic groups that have been shown by
the National Science Foundation to be underrepresented in healthrelated sciences on a national basis (see data at
http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 andthe report Women, Minorities, and Persons with Disabilities inScience and Engineering, 2007, p. 262). The following racial andethnic groups have been shown to be underrepresented in biomedical
research: African Americans, Hispanic Americas, Native Americans,
Alaskan Natives, Hawaiian Natives, and natives of the U.S. PacificIslands. In addition, it is recognized that under-representation canvary from setting to setting and individuals from racial or ethnic
groups that can be convincingly demonstrated to be underrepresented
by the grantee institution should be included in the recruitment andretention plan.

B.

Individuals with disabilities, who are defined as those with a physicalor mental impairment that substantially limits one or more major life
activities.

C.

Individuals from disadvantaged backgrounds who are defined as:
1. Individuals who come from a family with an annual income
below established low-income thresholds. These thresholds are
based on family size, published by the U.S. Bureau of the Census;
adjusted annually for changes in the Consumer Price Index; andadjusted by the Secretary for use in all health professions
programs. The Secretary periodically publishes these income
levels at http://aspe.hhs.gov/poverty/index.shtml. For individuals
from low income backgrounds, the institution must be able todemonstrate that such candidates (a) have qualified for Federal
disadvantaged assistance; or (b) have received any of thePart I: Instructions for Preparing and Submitting an Application

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following student loans: Health Professional Student Loans(HPSL), Loans for Disadvantaged Student Program; or havereceived scholarships from the U.S. Department of Health andHuman Services under the Scholarship for Individuals with
Exceptional Financial Need.
2. Individuals who come from a social, cultural, or educational
environment such as that found in certain rural or inner-city
environments that have demonstrably and recently directly
inhibited the individual from obtaining the knowledge, skills, andabilities necessary to develop and participate in a research career.
Recruitment and retention plans related to a disadvantaged
background (C1 and C2) are most applicable to high school andperhaps undergraduate candidates, but would be more difficult tojustify for individuals beyond that level of achievement. Under
extraordinary circumstances the PHS may, at its discretion,
consider an individual beyond the undergraduate level to be froma disadvantaged background. Such decisions will be made on acase-by-case basis, based on appropriate documentation.
New applications must include a description of plans to enhance
recruitment of a diverse trainee pool and may wish to include data insupport of past accomplishments. Renewal applications must include a
detailed account of experiences in recruiting individuals fromunderrepresented groups during the previous funding period. Information
should be included on both successful and unsuccessful recruitment
strategies.
History and Achievements. Describe efforts to recruit trainees fromDiversity groups A, B, and C into the existing training program. For
competing continuation/renewal applications, also describe past efforts torecruit and retain underrepresented minority students into training grant
funded positions. Refer to the data presented in Table 1 and Table 7A and
Table 7B that provided statistics on applications and admissions of thesegroups in comparison to the overall trainee pool.
For Renewal applications, complete Table 10 Admissions and Completion
Records for Underrepresented Minority (URM), Trainees with Disabilities,
and Trainees from Disadvantaged Backgrounds Clearly Associated with
the Training Program. New applicants may provide this data if they wish;
however, it is not required of new applicants.
Use this data to document the success of the program in recruiting andretaining trainees who are under-represented minorities, provide analysisof their support, and begin to establish a record of NIH training of other
Diversity Recruitment groups.
Proposed plans. Describe steps to be taken during the proposed award
period regarding the identification, recruitment, and retention of graduate
students and postdoctorates from underrepresented groups. Consider the
success and/or failures of recruitment strategies used in the past. In

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particular, describe the specific efforts to be undertaken by the training
program and how these might relate to the recruitment efforts of the
medical school, graduate school, and/or the university at large. In mostcases, institutional efforts alone will not satisfy the requirement to recruit
individuals from underrepresented groups.
Applications without a description of diversity recruitment efforts will beconsidered incomplete and may be delayed in the peer review process.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

5. Plan for Instruction in
the Responsible Conductof Research

Follow the page limits for Plan for Instruction in the Responsible Conductof Research in the table of page limits (Table 2.6-1), unless specified
otherwise in the FOA.
Please see NOT-OD-11-039.
A plan for Instruction in the Responsible Conduct of Research (RCR)
is required for all training grant activity codes except T36. Every
trainee must receive instruction in the responsible conduct of research. See
Supplemental Instructions Part III Section 1.16 for information on the NIH
Policy on Training in the Responsible Conduct of Research (RCR).
New applications must include a plan for instruction in the responsible
conduct of research. The plan should address how applicants plan toincorporate the five instructional parts outlined in the NIH Policy on
Training in the Responsible Conduct of Research: format, subject matter,
faculty participation, duration, and frequency. In addition, the plan mustdescribe how participation in RCR instruction will be monitored.
In addition, Renewal applications must describe any changes in formal
instruction over the past project period and plans for the future that address
any weaknesses in the current RCR instruction. All training faculty whoserved as course directors, speakers, lecturers, and/or discussion leadersduring the past project period must be named in the application.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.
This is a required attachment unless the FOA specifies otherwise.

6. Progress Report(Renewal Applications
Only)

State the period covered and briefly describe the accomplishments of the
training program. Describe any specific effects of this training program on
curriculum and/or research directions. Describe how the funds provided
under Training Related Expenses were used to benefit the program. For
each trainee supported during the period covered, indicate theirpreceptor/mentor, and briefly summarize the research conducted by thePart I: Instructions for Preparing and Submitting an Application

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trainee. For previous trainees appointed to the training grant andcontinuing in training, provide a brief statement of their status andprogress toward completion of their training program. Refer to data
presented in Table 6 Publications of Research Completed by Trainees (orPotential Trainees) and include in the table publications of trainees throughthe time that they complete their training for all trainees currently or
previously supported by the training grant program regardless of whether
support from this training grant is cited in the publication.
Complete Table 11 Appointments to the Training Grant For Each Year of
the Past Award (Renewal Applications Only).
Use this table to document the utilization of awarded training positions. If
any trainee positions were not filled, provide an explanation.
For programs that request only predoctoral trainee support, complete Table
12A Predoctoral Trainees Supported by this Training Grant (Renewal
Applications Only).
For programs that request only postdoctoral trainee support, complete
Table 12B Postdoctoral Trainees Supported by this Training Grant(Renewal Applications Only).
Programs requesting support (or reporting on prior support) for bothpredoctoral and postdoctoral trainees need to complete both Table 12A and
Table 12B.
Use these tables to document how predoctoral training positions are used
(i.e., distribution by mentor, year in program, years of support per trainee)
and the success of the program in achieving the training objectives of theprior award period(s) for up to 10 years. Summarize this data in the text.
If any postdoctoral trainee with a health professional degree appointed to
the grant during the most recent award period received less than 2 years of
research training, explain why. Where possible for past trainees, describe
the extent of their current involvement in research, including research
grant support and representative recent publications. Use the progress
report narrative to provide information that is not readily presented in therequired tables.
Renewal applications must include a detailed account of experiences inrecruiting individuals from underrepresented groups during the previous
funding period. Information should be included on both successful andunsuccessful recruitment strategies.
Renewal applications must describe the type of instructions provided in thecurrent project period, the degree of student participation, the results ofany assessments, and other relevant information.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

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7. Human Subjects

Complete this section if you answered “yes” to the question “are humansubjects involved?” on the R&R Other Project Information Form.
If trainee participation in research involving human subjects is solely as
part of other research projects that have received or will receive IRB
review and approval, and no portion of the Training Grant Award will be
used to support this research; provide a list of previously approved
research projects (grant number, PD/PI, and project title) and their IRB
approval dates or exemption designations. If plans are indefinite provide
an explanation and prior to trainee participation in other research project
grants, provide a list as indicated.
If the training program involves definite plans for the participation ofhuman subjects as defined in Supplemental Instructions Part III.3, Human
Subjects Research Definitions and Terms, outside of research projects thathave received or will receive IRB review, follow the instructions in
Supplemental Instructions Part II, Supplemental Instructions for Preparing
the Protection of Human Subjects Section of the Research Plan.
The appropriate grants must be identified along with their IRB approvaldates or exemption designation.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

8. Vertebrate Animals

Complete this section if you answered “yes” to the question “areVertebrate Animals Used?” on the R&R Other Project Information Form.
If the training program involves the use of live vertebrate animals solely as
part of other research project grants, and no portion of the Training Grant
Award will be used to support the purchase, use, or husbandry of live
vertebrate animals in this research; provide a list of previously approved
research projects (grant number, PD/PI, and project title) and IACUC
approval dates. If plans are indefinite provide an explanation and prior totrainee participation in other research project grants, provide a list as
indicated.
If the training program involves definite plans to use live vertebrate
animals outside of research projects that have received or will receive
IACUC approval, follow the instructions in Part I, 5.5, (Research Plan
Form), Vertebrate Animals.
The appropriate grants must be identified along with their IACUC
approval dates.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

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9. Select Agent Research

If participating faculty proposed in the training program are conducting orplan to conduct research involving select agents in which trainees may
participate, follow the instructions in Section 5.5, (Research Plan Form),
Select Agent Research.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

10. Multiple PD/PI
Leadership Plan

If you wish to submit a multiple PD/PI application, you must provide a
Leadership Plan. Do not submit a leadership plan if you are not submitting
a Multiple PD/PI application. For applications designating multiple
PD/PIs, all such individuals must be assigned the PD/PI role on the
Senior/Key Profile form, even those at organizations other than theapplicant organization. Refer to the instructions in Section 5.5 (Research
Plan Form), Multiple PD/PI Leadership Plan. However, the emphasis in a
training grant multiple PD leadership plan should be on how it will benefit
the program and the trainees. A single Contact PD must be designated forthe purpose of communicating with the NIH, although other individuals
may contact the NIH on behalf of the Contact PD when necessary.
Because training programs are intended to be coherent, NIH will not
allocate the budget or training positions between multiple PDs. A single
award will be made. Multiple PD plans should include reasonable numbersof PDs and each should be included for a specific purpose. Multiple-PD
applications should not include all mentors of the training grant as PDs,
except in unusual cases.
For background information on the Multi-PD/PI initiative, see:
http://grants.nih.gov/grants/multi_pi/index.htm.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

11. Consortium andContractual Arrangements

Describe any programmatic, fiscal, or administrative arrangements
between the applicant organization and other participating organizations.
See Section 5.5, Consortium/Contractual Arrangements for additional
guidance.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

12. Participating Faculty
Biosketches

Faculty Biosketches for participating faculty should follow the Additional
NIH and other PHS Agencies Instructions for a Biographical Sketch,
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faculty. These should be attached as a single document to avoid having to
upload large numbers of separate documents. However, the Biosketches of
the Program Director and other Senior/key Personnel should also beentered as described under SF424 (R&R) Section 4.5 Senior/Key Person
Profile (Expanded) Form.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

13. Data Tables

Instructions for Data Tables 1-12 mentioned above are located on the OER
website at the following URL
http://grants.nih.gov/grants/funding/424/index.htm#datatables. These
instructions include an Introduction to the Data Tables that provides
instructions applicable to all tables, specific instructions for each table, andSample Data Tables. The Sample Data Tables illustrate the kind of data toinclude in each table for Kirschstein-NRSA training grant applications. Be
sure to choose the Instruction and Blank Data Table set that corresponds tothe type of application you are submitting, e.g., New, Renewal, or
Revision Application, and the kind of training to be provided, e.g.,
predoctoral only, postdoctoral only, or pre and postdoctoral mixed.
Modification of these instructions for use in non-Kirschstein-NRSA
training grant applications will be included in relevant FOAs.
Save this information in a single file in a location you remember. Start
each numbered table on a new page. Bookmark the first page of eachtable by its table number (Table 1, Table 2, etc.) before you upload thefile. Click Add Attachment, browse to where you saved the file, select thefile, and then click Open.

14. Letters of Support

Attach appropriate letters here from all individuals confirming their rolesin the project. Letters documenting any agreements between the Program
Director(s) and senior administration officials or other institutional
officials are not required but may be included. For consultants, lettersshould include rate/charge for consulting services.
The Program Director should check the FOA (particularly for non-NRSA
programs) to determine if any program-specific letters of support are
required.
Save this information in a single file in a location you remember. Click
Add Attachment, browse to where you saved the file, select the file, andthen click Open.

15. Appendix

Do not use the appendix to circumvent the page limitations of the Training
Plan. All appendix material must be submitted as PDF attachments. A
summary listing all of the items included in the appendix is required, andshould be the first PDF file of the Appendix. Applications that do not

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follow the appendix requirements may be delayed in the review process.
Research publications of trainees and mentors are not normally included aspart of the Training Grant applications, but are allowed. Other types ofpublications reflecting on the activities of the program as a whole may also
be included. When publications are allowed, appendix materials should be
limited to those which are not publicly available, such as:•

Manuscripts and/or abstracts accepted for publication but not yet
published.

•

Published manuscripts and/or abstracts where a free, online,
publicly available journal link is not available.

•

Patents directly relevant to the project.

Publications that are publicly accessible must not be included in the
appendix. For such publications, the URL or PMC submission
identification numbers along with the full reference should be included as
appropriate in the Progress Report section of the Research Training
Program Plan, and/or in the Biographical Sketch.
Do not include unpublished theses or abstracts/manuscripts submitted but
not yet accepted for publication.
Some materials other than publications that are unique to training grantapplications (but not typically included in research grant applications) may
be included as appendices. In general, the appendix may be used toprovide samples of materials that are referred to in the body of theapplication, but are too cumbersome to include in the Research Training
Program Plan without disrupting the narrative flow. Examples include:i.

Syllabi for key courses, core courses and electives, including courses
in Responsible Conduct of Research, Survival Skills for Research,
etc.;
ii. Retreat, seminar series, and other program activity agendas, rosters,
and schedules;iii. Examples of forms used to document trainee progress and monitoringby the program;iv. Examples of materials used in recruitment and particularly recruitment
and retention to enhance diversity of the student pool;v. Lists of meetings attended by students and their presentations; andvi. Student biosketches.
As a reminder, tables other than the required Data Tables 1-12, must be
incorporated into the page limit of the Research Training Program Plan.
Follow the page limits for the Institutional Research Training and Career
Development Applicants, Including Ruth L. Kirschstein NRSA
Application in the table of page limits (Table 2.6-1), unless specified
otherwise in the FOA. These additional tables must not be included in the
appendix materials.

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8.8 Training Grant Peer Review Process
The goals of NIH-supported research training are to help ensure that a diverse pool of highly trained
scientists is available in adequate numbers and in appropriate research areas to address the Nation’s
biomedical, behavioral, and clinical research needs. The scientific review group will address and consider
each of criteria below in assigning the application’s overall score, weighting them as appropriate for eachapplication. Reviewers will first determine the quality of the proposed research training program,including information presented in the data tables and appendix, and then consider whether the requested
number of trainee positions is appropriate for the program.
The general process information (Overview, Streamlining, and Dual-Level Peer Review) found in Part I.6
applies to training grant applications as well. However, the actual review criteria and other review
considerations are different.
Review Criteria:•

Training Program and Environment•

Training Program Director/Principal Investigator (PD/PI)•

Preceptors/Mentors•

Trainees•

Training Record

Additional Review Criteria:•

Protection of Human Subjects from Research Risk•

Inclusion of Women, Minorities and Children in Research•Care and Use of Vertebrate Animals in Research•

Biohazards•

Resubmission Applications•

Renewal Applications

Additional Review Considerations:•

Training in the Responsible Conduct of Research•

Recruitment and Retention Plan to Enhance Diversity•

Budget and Period of Support

Applicants should carefully review the applicable FOA for complete information associated with the peer
review process. The FOA will describe essential information to be submitted for each of the above
elements.

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9.

Supplemental Instructions to the SF 424 (R&R) for
Preparing a Multi-Project Application

9.1 Introduction
The supplemental instructions found in this Section are for Multi-Project Applications (MPA) and include
guidance and instructional information only when there is a difference in the required information to besubmitted or there is a need for more specificity for an MPA. Therefore, these supplemental instructions
must be used along with the information found in Parts I.1 – I.6 of this document.
In FY2013 NIH began to transition multi-project applications to electronic submission using the SF424(R&R) application packages. This transition is done by activity code. As each code is added (see thetransition timeline), all applications submitted in response to Funding Opportunity Announcements(FOAs) for programs using that code will require electronic submission (including new, resubmission,
renewal and revision types of application). The requirement for electronic submission will be stated in
the FOA.

9.2 Multi-Project Applications
A Multi-Project Application is a single submission with multiple, interrelated components that share acommon focus or objective. A component is a distinct, reviewable part of a multi-project application forwhich there is a business need to gather detailed information as defined in a particular FOA. Eachcomponent includes the data collection identified for its specific component type. Components typically
include general information (component organization, project period, project title, etc.) performance sites,
personnel, and budget. They may also be referred to as cores or projects. The construction of theapplication and naming convention will be defined by the FOA.
Although MPAs submitted electronically will use application packages that use the SF424 (R&R) andPHS 398 forms, there are some differences in the way the multi-project application is structured. Every
application will include:•

A Single Overall Component: The Overall component describes the entire application andprovides an overview of how each of the additional components fit together.

•

Other Components: Other component types (e.g., Admin Core, Project, Core) will vary byopportunity. The component types will be specified in the FOA. Within ASSIST, only the
specified types of components will be available to choose from a drop-down menu during theapplication preparation process.

•

Summaries: Information automatically compiled from the data provided by the applicant in theindividual components and included in the agency assembled application (e.g., component andcategorical budget data) to help reviewers and staff work with the application. These are systemgenerated summaries and will be presented in the assembled application as part of the Overall
Component. Summaries will be generated for the follow information when applicable:
Performance Sites; Human Subjects, Clinical Trials, Human Embryonic Stem Cells, andVertebrate Animals; Budgets; and Senior/Key Personnel, including Biosketches.

It is imperative that applicants become familiar with the FOA for the specific MPA for which support isbeing requested. Before applying for an MPA, applicants should carefully review the applicable FOA
noting the special application instructions. When the instructions in the FOA differ from the instructions
given in the SF 424 (R&R) Application Guide or the ASSIST User Guide, the FOA instructions should be
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application, whether each component is optional or required and any restrictions on the number of times
each component can be included in a responsive application (e.g., 2-3 Projects are required). The FOA
will include specific information associated with the application and the names of individuals who may becontacted prior to submission of an application for additional or clarifying information.

9.2.1 Collaborating with Other Organizations
Components may be developed by the applicant institution or another organization. Applicants using
ASSIST will be able to delegate application preparation responsibilities to multiple users within andoutside the applicant organization while maintaining appropriate access control and security. Refer to the
ASSIST User Guide for additional guidance.
Depending on the role of the collaborating organization in the overall project, there are two approaches toconstructing the application.
1.

Collaborating Organization as the Lead in an Other Component: The applicant organization isalways identified in the Overall component. However, when an entire Other Component is led by adifferent subaward/consortium organization complete, all the forms for that Other Component(including the R&R Cover Form and Budget Form) using the subaward/consortium organization’s
information. On the Budget Form, use the Budget Type “Project” (marked on top of the form) andthe subaward/consortium organization’s DUNS and Name. ASSIST will automatically calculate thebudget information as a consortium/subaward to the Overall Component’s applicant organization.

2.

Collaborating Organization as a Consortium in an Other Component: When a collaboratingorganization is not the lead in an Other Component, then that organization will be represented as aconsortium/subaward. In this scenario the applicant organization is the lead on the Other
Component. Therefore, complete all the forms for the Other Component (including the R&R CoverForm and Budget Form) using the applicant organization’s information. On the Budget Form, use
the Budget Type “Project” (marked on the top of the form) and the applicant organization’s
information. To add the subaward/consortium budget, on the “Summary” tab for the component use
the “Add Optional Form” action to add another R&R budget form. Indicate Budget Type
“Subaward/Consortium”, and complete this form using the information for the subaward/consortium
organization. ASSIST will automatically calculate this information as a subaward to the applicant
organization.

9.3 Application Submission System & Interface for
Submission Tracking (ASSIST)ASSIST is a web-based interface for the preparation and submission of multi-project applications.
ASSIST is accessed using existing eRA Commons credentials with any of the following roles: Signing
Official (SO), Administrative Official (AO), Principal Investigator (PI), Assistant (ASST) or Account
Administrator (AA). Most applicants do not need to complete additional registrations to use the system.
ASSIST allows applicants to:•

Use current eRA Commons credentials to access ASSIST•

Populate data from established eRA Commons profiles•

Run federal-wide and agency business rule validations prior to submission•

Take advantage of automatic generation of the table of contents, headers, footers, page numbers,
etc.

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Print/preview applications in the format used by the agency prior to submission including systemgenerated data summaries•

Present to reviewers clear, color PDF images, rather than scanned versions of the application•

Avoid the hassle of preparing and shipping multiple paper copies

Applicant organizations that use system-to-system solutions will be able to use those services, in lieu of
ASSIST, for submitting multi-project applications into Grants.gov if their provider offers the service.
The ASSIST User Guide contains detailed instructions for using ASSIST to complete the MPA
application. Instructions for the specific requirements of an MPA (e.g. types of components, page limits)
are found in the individual FOA. In addition to the guidance included in this application guide and the
ASSIST User Guide, the following resources are also available:•

Multi-Project Applications section of the Applying Electronically website•

Electronic Multi-Project Application: Annotated SF424 (R&R) Form Set•

Frequently Asked Questions•“Tips” section at the top of each form tab in ASSISTASSIST uses a combination of web-based data entry screens and PDF file attachments to compile therequired data elements of an application. The information entered in the data screens is the same as theinformation requested in the SF424 (R&R) and PHS 398 forms and the instructions for completing thedata elements are the same, unless noted otherwise in this section of the application guide or within the
FOA.
Table 9.3-1 ASSIST Data Forms
DATA COLLECTION

OVERALL COMPONENTOTHER COMPONENTSF424 R&R CoverYes

Yes (some data items)

PHS 398 Cover Page Supplement

Yes

Yes

SF424 R&R Other Project Information

Yes

Yes

SF424 R&R Project/Performance Sites

Yes

Yes

SF424 R&R Senior/Key Person Profile

Yes

Yes

SF424 R&R Budget

No

Yes

SF424 R&R Subaward Budget Attachment

No

Optional

PHS 398 Research Plan

Yes

Yes

Planned Enrollment Report

No

Optional

PHS398 Cumulative Inclusion Enrollment Report

No

Optional

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Special Note on Structuring the Application: The assembled application image created for an MPA application
has a predetermined order. The Overall Component is always first and includes the system-generated datasummaries. Other component types follow in alphabetical order (e.g., Cores before Projects). Components of thesame type are grouped together in the order created in ASSIST and given sequential numbers (e.g., Core-001,
Core-002, Project-001, Project-002). Applicants do not have the ability to reorder components within ASSIST.
Therefore, some planning should be done before initiating components. For more information on MPA applicationassembly, see http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multiproject_Application_Image_Assembly.pdf.

9.4 Special Instructions to the SF424 R&R for Multi-Project
Applications
Standard instructions found in Parts I.4 – I.5 apply to the Overall Component and all Other Components
with the exceptions found in this section. For each Form, follow the detailed corresponding instructionsin Part I. Sections 4 & 5 as well as the exceptions noted below.

9.4.1 Special Instructions for 4.2 Cover Form
DATA ITEM/FIELD NAME
General Instructions

OVERALL COMPONENTOTHER COMPONENTS

All the SF424 (R&R) Cover form
fields are collected for the Overall
Component.

Only a subset of data fields from the CoverComponent is collected for the Other
Components. These are:
5. Applicant Information
7. Type of Applicant (optional)
11. Descriptive Title
12. Proposed Project
ASSIST: Fields are not automatically
populated. Use Expand All to expose thefields available for data entry. Fields that are
grayed out do not need to be completed.

5.

Applicant Information

This information is for the
Applicant Organization, not a
specific individual.

ASSIST: Applicant Information
DUNS and address fields are
populated from the Commons
Institutional Profile for theorganization selected when theapplication was initiated and are
not editable.

ASSIST: Fields that are grayed out do notneed to be completed.

The Contact email is required by
NIH for the Overall Component. If
not included, or improperly
formatted, the AOR e-mail address
will be used.
7.

Type of Applicant

Required for Overall Component.

Optional for Other Components.

This information is for the
Applicant Organization, not a
specific individual AOR or
PD/PI.

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DATA ITEM/FIELD NAMEOVERALL COMPONENTOTHER COMPONENTS

14. Project
Director/Principal
Investigator Contact
Information

ASSIST: The PD/PI information for
the Overall Component is
automatically populated from the
PD/PI section of the SF 424 (R&R)
Senior/Key Person Profile(Expanded) form. The information
is not editable in the SF424 (R&R)
Cover form. Any changes must be
made on the Senior/Key Person
Profile form.

Not collected for Other Components.

15. Estimated Project
Funding

Required for Overall Component

Not collected for Other Components.

ASSIST: Data must be manuallyentered.

9.4.2 Special Instructions for 4.3 Project/Performance Site Locations
A summary of Performance Sites for all Components will appear in the Overall section of the assembled
application image in eRA Commons and will be generated upon submission.
DATA ITEM/FIELD NAME
General Instruction

OVERALL COMPONENTOTHER COMPONENTS

Include only the Primary Site in theOverall Component.

List all performance sites that apply
to the specific component.

A summary of Project/Performance
Sites in the Overall section of theassembled application image ineRA Commons compiled from datacollected in the other components
will be generated upon submission.
ASSIST: Summary Performance
Site information is available whenusing “Preview Application.”
DUNS Number

The DUNS is a required field for the
primary performance site in both theOverall and Other Components.

The DUNS is a required field for the
primary performance site in both theOverall and Other Components.

9.4.3 Special Instructions for 4.4 Other Project Information
Component
When applicable, a summary of Human Subjects, Clinical Trials, Human Embryonic Stem Cells, andVertebrate Animals for all Components will appear in the Overall section of the assembled application
image in eRA Commons and will be generated upon submission.
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DATA ITEM/FIELD NAMEOVERALL COMPONENTAre human subjects
involved?

If activities involving human subjects are plannedat any time during the proposed project at any
performance site and/or on any Other Component,
check Yes for the Overall Component andcomplete the remaining questions as instructed in
4.4 using the unique guidance below for selected
data items.

Answer only the “Are
Human Subjects
Involved?” and “Is the
Project Exempt fromFederal regulations?”
questions for Other
Components.

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

Complete for both the Overall and Other
Components. If the Overall Component
exemption is E4 then no other exemption number
can be set for any Other Component.

Complete for both theOverall and Other
Components. If theOverall Component
exemption is E4 then noother exemption number
can be set for any Other
Component.

IRB Approval Date

Complete only for the Overall Component whenapplicable.

Not collected for Other
Components.

Human Subject Assurance
NumberComplete only for the Overall Component whenapplicable.

Not collected for Other
Components.

2.

If activities involving vertebrate animals areplanned at any time at the Overall Component orat any Other Component, at any performance site,check yes on the Overall component andcomplete the remaining questions as instructed in
4.4 using the unique guidance below for selected
data items. If no, skip the rest of block 2.

Answer only the “AreVertebrate Animals Used?”question.

Is the IACUC review
Pending?

Complete only for the Overall Component whenapplicable.

Not collected for Other
Components.

IACUC Approval Date

Complete only for the Overall Component whenapplicable.

Not collected for Other
Components.

Animal Welfare Assurance
NumberComplete only for the Overall Component whenapplicable.

Not collected for Other
Components.

6.

Does this project
involve activities
outside of the UnitedStates or partnerships
with international
collaborators?

Complete at both the Overall and Other
Component Levels. However, if Yes on any Other
Component, then the answer must be Yes for theOverall Component.

Complete at both theOverall and Other
Component Levels.
However, if Yes on any
Other Component, thenthe answer must be Yes
for the Overall Component.

8.

Project Narrative

Required for Overall Component.

Optional for Other
Components. See
specific FOA to see if thisis required for any Other
Components.

1.

Are Vertebrate Animals
Used?

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9.4.5 Special Instructions for 4.5 Senior/Key Person Profile(Expanded)
A summary of Senior/Key Persons followed by their Biographical Sketches will appear in the Overall
section of the assembled application image in eRA Commons and will be generated upon submission.
DATA ITEM/FIELD NAME
General Instruction

OVERALL COMPONENTOTHER COMPONENTS

Only list the Contact PD/PI and any MultiPD/PIs; all with role PD/PI on the Overall
Component. Do not list any other
Senior/Key personnel for the Overall
Component.

List all personnel who are
Senior/Key to the specificcomponent.

Required by NIH for the Overall and Other
Components.

Required by NIH for the Overalland Other Components.

ASSIST: Overall Component contact PD/PI
Organization name is pre-populated fromSF 424 (R&R) organization.

ASSIST: Overall Component
contact PD/PI Organization nameis pre-populated from SF 424(R&R) organization.

Project Role

Must be PD/PI on Overall Component.

Unless otherwise specified in the
FOA, in the Project
Director/Principal Investigator
section of the form, use Project
Role of “Other” with Category of“Project Lead.”

Credential, e.g. agency
login

Must provide the eRA Commons
username for all PD/PIs.

Provide the eRA Commons
username for person identified in
the Profile – Project
Director/Principal Investigator
section of the form (typically
Project Lead).

Attach Biographical Sketch

Each Senior/Key individual, including the PD/PI, is allowed one biosketch for theentire application. If an individual will participate on multiple components, chose
any single entry to attach the biosketch, make sure it reflects participation oneach relevant component.

Organization Name

The PD/PI role should not be used
for any personnel in Other
Components.

The PD/PI(s) may include the biosketch in the Overall Component or any Other
Component.
Biosketches will not be repeated within each component in the application
image.
ASSIST: Summary information available when using “Preview Application.”

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9.4.6 Special Instructions for 4.7 R&R Budget
The only budget information included in the Overall component is the Estimated Project Funding sectionof the SF424 (R&R) Cover form. Complete a budget, including appropriate subaward budgets whenapplicable, for the Other Components.
For information on preparing budgets when collaborating organizations are involved, see Section 9.2.1.
Budget summaries will appear in the Overall section of the assembled application image in eRA
Commons, will be compiled from detailed budget data collected in the Other Components, and will be
generated upon submission.
ASSIST: Summary budget information is available when using “Preview Application.”

9.4.7 Special Instructions for 5.3 PHS 398 Cover Page Supplement
When applicable, a summary of Human Subjects, Clinical Trials, Human Embryonic Stem Cells, andVertebrate Animals for all Components will appear in the Overall section of the assembled application
image in eRA Commons and will be generated upon submission.
DATA ITEM/FIELD NAMEOVERALL COMPONENTOTHER COMPONENTS

1.

Project Director/Principal
Investigator

ASSIST: Not editable. Section is
populated from SF 424 (R&R)
Sr/Key Person Profile PD/PI section.
Any changes must be made on thatform for the Overall Component.

Not Applicable to Other
Components. Note this field reflects
the PD/PI for the entire application,
not the project lead for the Other
Component.

2.

Human Subjects/Clinical
Trial?

Complete at both the Overall andOther Component Levels. However,if Yes on any Other Component,
then the answer must be Yes on theOverall Component.

Complete at both the Overall andOther Component Levels. However,if Yes on any Other Component,
then the answer must be Yes on theOverall Component.

Agency-Defined Phase III
Clinical Trial?

Complete at both the Overall andOther Component Levels. However,if Yes on any Other Component,
then the answer must be Yes on theOverall Component.

Complete at both the Overall andOther Component Levels. However,if Yes on any Other Component,
then the answer must be Yes on theOverall Component.

3.

Complete at both the Overall andOther Component Levels. However,if Yes on any Other Component,
then the answer must be Yes on theOverall Component.

Complete at both the Overall andOther Component Levels. However,if Yes on any Other Component,
then the answer must be Yes on theOverall Component.

All cell lines from Other
Components must be manuallyentered in the Overall Component
cell line table.

List all cell lines that pertain to thespecific component.

Human Embryonic Stem Cell
Does the proposed project
involve human embryonicstem cells?

Cell Lines

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9.4.8 Special Instructions for 5.5 PHS 398 Research Plan
DATA ITEM/FIELD NAMEOVERALL COMPONENTOTHER COMPONENTS

1. Introduction to Application

For Resubmission and Revisionapplications, an Introduction to
Application is required on theOverall Component, but may beallowed for each Other Component
unless otherwise stated in the FOA.

For Resubmission and Revisionapplications, an Introduction to
Application is required on theOverall Component, but may beallowed for each Other Component
unless otherwise stated in the FOA.

10. Multiple PD/PI Leadership
Plan

Required if more than one PD/PI is
specified on R&R Senior/Key
Person Profile form of the Overall
Component.

Not applicable.

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