SF424 (R&R) Application Guide for NIH and Other PHS Agencies

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 and

other 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

SF424(R&R) ii

TABLE OF CONTENTS

PART I. INSTRUCTIONS FOR PREPARING AND SUBMITTING AN APPLICATION

1. Foreword ............................................................................................................................................... 1

1.1 Application Guide Format ............................................................................................................ 3

1.2 NIH Extramural Research and Research Training Programs ....................................................... 4

1.3 Research Grant Activity Codes and Program Guidelines ............................................................. 4

1.4 Interactions with PHS Staff .......................................................................................................... 5

1.5 Grants Policy Statements .............................................................................................................. 8

1.6 References .................................................................................................................................... 8

1.7 Authorization .............................................................................................................................. 10

1.7.1 Collection of Personal Demographic Data ................................................................... 10

1.8 Paperwork Burden ...................................................................................................................... 10

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

2.1 Overview .................................................................................................................................... 11

2.2 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 Submi

tting 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

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

SF424(R&R) iii

2.16.2 Finding Help for the eRA Commons Registration or eRA Commons Validation

Processes ...................................................................................................................... 37

2.16.3 Finding Help for Application Preparation ................................................................... 38

3. Using the Grant Application Package .............................................................................................. 38

3.1 Verify Grant Information ............................................................................................................ 38

3.2 Enter the Name for the Application ............................................................................................ 39

3.3 Open and Complete Mandatory Documents ............................................................................... 39

3.4 Open and Complete Optional Documents .................................................................................. 39

3.5 Submitting the Application via Grants.gov ................................................................................ 40

4. Completing the SF424 Research and Related (R&R) Forms ......................................................... 40

4.1 Overview .................................................................................................................................... 40

4.2 Cover Form ................................................................................................................................. 41

4.3 Project/Performance Site Locations Form .................................................................................. 57

4.4 Other Project Information Form ................................................................................................. 61

4.5 Senior/Key Person Profile (Expanded) Form ............................................................................. 68

4.6 Selecting the Appropriate Budget Form ..................................................................................... 77

4.7 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

4.8 Special Instructions for Preparing Applications with a Subaward/Consortium ......................... 93

5. Completing PHS 398 Form ................................................................................................................ 97

5.1 Overview .................................................................................................................................... 97

5.2 (Reserved) ................................................................................................................................... 98

5.3 Cover Page Supplement Form .................................................................................................... 98

5.4 Modular Budget Form .............................................................................................................. 103

5.4.1 Budget Period Form ................................................................................................... 105

5.4.2 Cumulative Budget Information ................................................................................ 107

5.5 PH

S 398 Research Plan Form................................................................................................... 109

5.6 (Reserved) ................................................................................................................................. 120

5.7 (Reserved) ................................................................................................................................. 120

5.8 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

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

SF424(R&R) iv

7.2 Individual Career Development Award Programs .................................................................... 130

7.3 Letters of Reference (must be submitted electronically through the eRA Commons) ............. 131

7.4 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

7.5 PHS 398 Career Development Award Supplemental Form ..................................................... 140

7.6 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 Introduction .............................................................................................................................. 161

8.2 Institutional Research Training Programs ................................................................................ 162

8.3 Reserved ................................................................................................................................... 162

8.4 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

8.5 PHS 398 Training Budget ......................................................................................................... 165

8.6 PHS 398 Training Subaward Budget Attachment(s) Form ...................................................... 171

8.7 Research Training Program Plan Form .................................................................................... 174

8.8 Training Grant Peer Review Process ........................................................................................ 189

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

9.1 Introduction .............................................................................................................................. 190

9.2 Multi-Project Applications ....................................................................................................... 190

9.2.1 Coll

aborating with Other Organizations .................................................................... 191

9.3 Application Submission System & Interface for Submission Tracking (ASSIST) .................. 191

9.4 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

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

SF424(R&R) v

9.4.7 Special Instructions for 5.3 PHS 398 Cover Page Supplement ................................. 197

9.4.8 Special Instructions for 5.5 PHS 398 Research Plan ................................................. 198

PART I

Instructions for Preparing and Submitting

an Application

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

Part I: Instructions for Preparing and Submitting an Application I-1

1. Foreword

Forms Version C Application Guide — Released July 25, 2013

This 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 the

additional 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 no

longer be used. However, NIH will continue to keep the Cover Letter separate from the

assembled 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 and

associated 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.

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

Part I: Instructions for Preparing and Submitting an Application I-2

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 data

rather 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, and

Consultants.”

• 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 (as

applicable).”

• 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 no

longer be used.

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

Part I: Instructions for Preparing and Submitting an Application I-3

• 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 multi-

component applications to accommodate their transition to electronic submission effective with

submissions 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-specific

forms 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 and

Grants.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, and

revision 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 and

Prevention (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 specific

instructions for completing the application forms as well as information on electronically submitting

applications through Grants.gov.

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

Part I: Instructions for Preparing and Submitting an Application I-4

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: GrantsI[email protected]

by 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 the

descriptions 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)

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

Part I: Instructions for Preparing and Submitting an Application I-5

• 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)

AWARDING COMPONENT

(LINK TO WEBSITE)

TELEPHONE

NUMBER

National Institutes of Health

(NIH)

Eunice Kennedy Shriver National Institute of Child Health and

Human Development

301-496-0104

NIH Fogarty International Center 301-496-1653

NIH National Cancer Institute 301-496-3428

NIH National Center for Complementary and Alternative Medicine 301-496-4792

NIH National Center for Advancing Translational Sciences 301-496-6023

NIH National Eye Institute 301-451-2020

NIH National Heart, Lung, and Blood Institute 301-435-0260

NIH National Human Genome Research Institute 301-496-7531

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 Research 301-594-4800

NIH National Institute of Diabetes and Digestive and Kidney Diseases 301-594-8834

NIH National Institute on Drug Abuse 301-443-2755

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

Part I: Instructions for Preparing and Submitting an Application I-6

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 Sciences 301-594-4499

NIH National Institute of Mental Health 301-443-3367

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 Research 301-594-6906

NIH National Library of Medicine 301-496-4621

NIH Center For Scientific Review 301-435-0715

Agency for Healthcare

Research and Quality

Agency for Healthcare Research and Quality 301-427-1447

Centers for Disease Control

and Prevention (CDC)

Coordinating Center for Health Information and Services 404-498-1186

CDC Office of Infectious Disease 404-639-3770

CDC National Center for Environmental Health 770-488-4668

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 Health 404-498-2530

CDC Procurement and Grants Office 770-488-2700

Food and Drug

Administration

Food and Drug Administration 301-827-7185

Indian Health Service Indian Health Service 301-443-0578

Agency for Toxic

Substances and Disease

Registry

Agency for Toxic Substances and Disease Registry 404-842-6630

Office of Public Health and

Science

Office of Population Affairs 301-594-4004

Office of Public Health and

Science

Office of Family Planning 301-594-4008

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.

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

Part I: Instructions for Preparing and Submitting an Application I-7

• 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 non-

NIH 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 Health

6701 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 scientific

content of an application or an attempt to influence review outcomes will create serious breaches of

confidentiality in the review process. Reviewers are required to notify the Scientific Review Officer if

they 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 and

applicant organizations in the eRA Commons in a new “Correspondence” section of the Commons

detailed status screen for the application. Applicants will be notified by email to check their Commons

account. 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 send

additional/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:

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

Part I: Instructions for Preparing and Submitting an Application I-8

• 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 compilation

of the salient features of policies and various policy issues regarding the administration of grant

awards 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 can

check assignment/contact information, review outcome, and other important information. For more

details on Commons registration, see Section 2.2.2

E-mail: [email protected]ih.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.

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

Part I: Instructions for Preparing and Submitting an Application I-9

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: Grant[email protected]

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 extramural

community 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.

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

Part I: Instructions for Preparing and Submitting an Application I-10

1.7 Authorization

The PHS requests the information described in these instructions pursuant to its statutory authorities for

awarding grants, contained in Sections 301(a) and 487 of the PHS Act, as amended (42 U.S.C. 241a and

42 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 an

application 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 a

continuing assessment of research personnel needs. Personal demographic data on PD/PIs and those with

a 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 the

data entry in the Commons Personal Profile, the individual is responsible for providing true, accurate, and

complete 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 identification

of individuals and for management of PHS grant programs. Please be aware that no individual will be

denied 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 as

amended (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 regular

research 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 a

currently 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 other

aspect 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 (0925-

0001). Do not send applications or any materials related to training or career award applications to this

address.

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

Part I: Instructions for Preparing and Submitting an Application I-11

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 Award

Management (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 your

organization 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 already

completed 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 the

requirements 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 Commons

must 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 the

assembled application correctly reflects their submission. (See Section 2.11

for detailed

information.)

The following sections explain each step in more detail.

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

Part I: Instructions for Preparing and Submitting an Application I-12

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 this

section 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 one-

time 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 Award

Management (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 registration

in SAM which requires renewal at least annually. This requires that you review and update the

information at least annually after the initial registration, and more frequently if required by changes in

your 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. Foreign

organizations 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 your

entity 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 the

applicable 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 [email protected]

. 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 role

must have an eRA Commons ID for reporting on awarded grants. Access to the Commons is vital for all

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

Part I: Instructions for Preparing and Submitting an Application I-13

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 Commons

registration. 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 an

application. 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 the

successful submission of an electronic application to NIH. Commons user name IDs for those with a

postdoctoral 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 page

a. The Signing Official (SO) must sign, date and fax the registration to the number listed

on 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 email

b. The above steps must be completed before NIH can process the registration

c. 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 created

during the registration process

5. Log into Commons

a. 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

eRA Commons if they do not have an existing account. If they have an account, you

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

Part I: Instructions for Preparing and Submitting an Application I-14

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 this

field in the organization profile in Commons.

To confirm that your organization has a DUNS number or to find out if the DUNS number you have

matches 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 Role

Once 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 such

individuals 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 must

verify that all Personal Information located within the Personal Profile tab in the eRA Commons System

is 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 most

recent 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 within

eRA 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 with

different user names – one with SO authority and one with PI authority. When an organization is

registered, an SO account is created. Log on to the account with the SO authority role and create another

account 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 the

eRA 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).

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

Part I: Instructions for Preparing and Submitting an Application I-15

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, applicants

need 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 be

submitted 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 the

appropriate 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 ( ), and

period (.). 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 a

list 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 the

required PDFs. Instead, NIH recommends producing the documents electronically using text or word-

processing software and then converting documents to PDF. Scanning paper documents, without the

proper Optical Character Recognition (OCR) process, will hamper automated processing of your

application 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 or

other PHS agencies, any other agency of the United States Government, or any employee of the United

States 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.

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

Part I: Instructions for Preparing and Submitting an Application I-16

2.4. Funding Opportunities

Grants for health-related research and research training projects or activities make up the largest category

of 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 for

research or research training within an area that is relevant to the NIH. Research project grants are

awarded 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 the

facilities 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 high

priority 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 at

that 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 indicates

the 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 usually

reviewed by a Scientific Review Group (SRG) specially convened by the awarding component that issued

the RFA.

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

Part I: Instructions for Preparing and Submitting an Application I-17

PAs (including Parent Announcements) and RFAs are published in the NIH Guide for Grants and

Contracts (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 for

special instructions. The instructions in the announcement may differ from these general instructions, and

the 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 of

announcements.

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 due

date(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 pre-

populated. Do not go strictly by this date since it may not apply to your particular situation; for

instance, 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 be

announced 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 specific

application 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.

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

Part I: Instructions for Preparing and Submitting an Application I-18

Using “Find Grants” (Find) Feature

Grants.gov Find provides general search capabilities. From the “Search Grants” page, you will find

various 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. “Step

1” 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 this

number in the Funding Opportunity Number field and click Download Package. This takes you to a

“Selected Grant Applications for Download” screen.

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

Part I: Instructions for Preparing and Submitting an Application I-19

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 to

determine the appropriate package to download. The following screens appear:

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

Part I: Instructions for Preparing and Submitting an Application I-20

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 specific

information regarding the forms for an Application Package. Section 3

provides additional instructions for

properly using a package.

On the Download Opportunity Instructions and Applications screen you will be given an opportunity to

provide 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.

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

Part I: Instructions for Preparing and Submitting an Application I-21

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

DOCUMENT

REQUIRED

OPTIONAL

INSTRUCTIONS

SF424 (R&R) Cover

Section 4.2

SF424 (R&R) Project/Performance Site Locations

Section 4.3

SF424 (R&R) Other Project Information

Section 4.4

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

Section 4.5

SF424 (R&R) Budget

(Use when required or allowed by the FOA)

Section 4.7

SF424 (R&R) Subaward Budget Attachment Form

(Use when required or allowed by the FOA)

Section 4.8

PHS 398 Cover Page Supplement

Section 5.3

PHS 398 Modular Budget

(Use when required or allowed by the FOA)

Section 5.4

PHS 398 Research Plan

(Not required for Career Development Award (K)

Institutional Training Award (T) applications)

Section 5.5

Planned Enrollment Report

Section 5.8

PHS 398 Cumulative Inclusion Enrollment Report

Section 5.8

PHS 398 Career Development Award Supplemental

Form

(Required only for Career Development Award (K)

applications)

Section 7.5

PHS 398 Research Training Program Plan

(Required only for Institutional Training Award (T)

applications)

Section 8.7

PHS 398 Training Budget

(Use when required or allowed by the FOA)

Section 8.5

PHS 398 Training Subaward Budget Attachment

(Use when required or allowed by the FOA)

Section 8.6

* 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 application

must 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 and

submit 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 the

optional list).

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

Part I: Instructions for Preparing and Submitting an Application I-22

For a small number of programs (e.g., S10, DP1, DP2, DP3, X01, X02), neither budget form is included and the

only 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 a

complete 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 or

delay 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 ( ), and

period (.). 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.

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

Part I: Instructions for Preparing and Submitting an Application I-23

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 system-

generated 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 that

when 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 the

internet 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 the

application 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.

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

Part I: Instructions for Preparing and Submitting an Application I-24

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.

PAGE LIMITS *

Introduction to Resubmission Application

(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)

1 page

Introduction to Revision Application

1 page

Specific Aims

1 page

Research Strategy (Item of Research Plan)

6 pages

or 12 pages

or Follow FOA instructions

Research Education Program Plan

For R25 Research Education Grant Applications

25 pages

Plan for Instruction in the Responsible Conduct of Research

Required for all Training Grant Activity Codes

Required for all Individual Career Development Grant Activity Codes

3 pages

1 page

Biosketch (per person)

(2 pages for DP1 and DP2 Activity Codes)

4 pages

Career Development Award (K) Application

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) and

Research Strategy attachment

12 pages

Institutional Research Training and Career Development Applicants,

Including Ruth L. Kirschstein NRSA Application

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)

25 pages

* 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 by

significant 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-

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

Part I: Instructions for Preparing and Submitting an Application I-25

12-128). After 37 months, you may submit a New application. Any second resubmission will be

administratively 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, and

changes to the application. The Introduction must also include a response to the issues and

criticism 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 the

relevant 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 essentially

all 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 for

standard 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 other

applications 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 particular

field 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 more

significant 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.

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

Part I: Instructions for Preparing and Submitting an Application I-26

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 this

policy. 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 for

a significant expansion of a project’s scope or research protocol. Applications for revisions are not

appropriate when the sole purpose is to restore awards to the full SRG-recommended level if they were

administratively 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 contain

sufficient 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 application

that 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 the

scope 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 in

advance 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 authorized

Business Official and describe the need for additional funding and the categorical costs. In the letter, point

out 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

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

Part I: Instructions for Preparing and Submitting an Application I-27

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 grant

application. 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 be

delayed 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 an

individual 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 of

applications 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 with

the 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 have

successfully 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 (of

both 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 to

ensure enough time to correct any errors before the deadline.

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

Part I: Instructions for Preparing and Submitting an Application I-28

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 also

by 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 and

validated 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 retrieved

by 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: [email protected]

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 (not

Grants.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 the

application 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 the

Applicant 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 first

submitted. The Grants.gov system will indicate that the agency tracking number has been assigned, and

will 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.

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

Part I: Instructions for Preparing and Submitting an Application I-29

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 check

the assembled application before it automatically moves forward to NIH staff for further processing and

consideration. 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 the

submission process. After an application is rejected, a changed/corrected application can be submitted to

address 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 in

warnings (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 as

long 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 link

from the Action column of the search hit list.

To view the assembled application the PD/PI should:

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

Part I: Instructions for Preparing and Submitting an Application I-30

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, the

application will be considered late. In this case, applicants must include a cover letter explaining the

reasons for the delay and acceptance will be considered on a case-by-case basis. Also see Section 2.14

for

additional 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/errors

that were encountered during the validation process. The eRA system will make every effort to send an e-

mail 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 their

application 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 formatting

that 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 may

need to be addressed later in the process.

Failure to comply with stated NIH policies can also result in a submitted application being returned to the

applicant 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 and

password.

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

Part I: Instructions for Preparing and Submitting an Application I-31

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 automatically

display a hit list of your applications.

5. A hit list of applications is displayed. If the application was validated with warnings only, or

without 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, and

refers 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 of

errors/warnings.

7. The error/warning page appears, and you are then able to review all conditions that were

identified during validation. If only warnings were identified, you may elect to take action and

resubmit; 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 the

application. Most often this means that you have to edit the data within the application forms to

correct whatever problem or inconsistency that was noted. Be as careful as possible when

correcting 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 no

guarantees that applications submitted after the due date will be accepted. See the NIH

late policy for more information.

o When you check the Changed/Corrected Application box, Previous Grants.gov Tracking

ID field becomes required.

o When 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 your

application 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.

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

Part I: Instructions for Preparing and Submitting an Application I-32

The same e-mail notifications will be issued once the agency has downloaded and validated the re-

submitted 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 initial

peer review if they result from unforeseen administrative issues. Exceptions to this policy are indicated

below. 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 e-

mail is not feasible, please send in a hard copy.

The original application is kept intact; any application material sent post-submission is sent separately to

reviewers. 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 loss

of 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 application

material. The news must be received by the Scientific Review Officer one month (30 calendar

days) 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 this

update 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 (K

series)] applications, the following types of information will be accepted:

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

Part I: Instructions for Preparing and Submitting an Application I-33

o News of a trainee's or former trainee's graduation, employment, promotion, funding,

publication or other professional achievement since the training grant was submitted;

o News of a faculty member's promotion, funding, publication, or other professional

achievement since the training grant was submitted; and

o News 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-OD-

10-070

• 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 post-

submission 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 size

as 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 page

The 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.

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

Part I: Instructions for Preparing and Submitting an Application I-34

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 initial

peer 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 the

entire 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 the

announcement, 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 are

submitted 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 to

Grants.gov on or before 5 p.m. local time on the appropriate date listed. Applications submitted for

Special 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 or

Federal holiday, the application deadline is automatically extended to the next business day. If the

submission deadline shifts beyond the expiration date of the FOA, applicants submitting electronically

may receive a warning message from Grants.gov. This warning will not keep your application from

processing through Grants.gov. As always, applicants must check the eRA Commons to view their

application and to ensure they have addressed any errors (instances of non-compliance with NIH business

rules) identified by NIH systems.

Modified Application Submission and Review Policy. A continuous submission process is available to

appointed 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 and

review 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, late

applications 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 the

processing time required for two different kinds of submission/receipt dates.

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

Part I: Instructions for Preparing and Submitting an Application I-35

• 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 late

applications can be processed with the cohort of on-time applications. In all cases, when the regular

standard submission date or expedited submission date falls on a weekend or federal holiday and is

extended 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 Cover

Letter 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/notice-

files/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 be

assigned 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.

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

Part I: Instructions for Preparing and Submitting an Application I-36

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 each

application to the agency awarding component that is the potential funding component. When the

scientific 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 such

components. The component that has the most relevant program responsibility is designated as the

primary 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 these

suggestions 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 be

able 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 place

in 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 an

application 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 of

assignment to the time the review of your application is complete, applicant investigators must direct all

questions 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 an

application through the Grants.gov system, check first the resources available at Grants.gov

(http://grants.gov/

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

Part I: Instructions for Preparing and Submitting an Application I-37

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 or

eRA 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 the

application validation process in the Commons after submission through Grants.gov, check first the

resources 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: [email protected].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

• Signing Official’s (SO) Username

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

Part I: Instructions for Preparing and Submitting an Application I-38

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: [email protected]

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

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

Part I: Instructions for Preparing and Submitting an Application I-39

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 are

posted in Grants.gov showing an Open/Close period that spans the entire 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 the announcement, applicants should refer

to 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 2.14

of 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 name

is 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 other

mandatory 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 for

specific types of grant activities. Information on each of these documents is found later in these

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

Part I: Instructions for Preparing and Submitting an Application I-40

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 the

form, 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 successfully

completed 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 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 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 a

field, 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 or

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

Part I: Instructions for Preparing and Submitting an Application I-41

PHS business processes. Agency validations will be performed by the eRA Commons system

after 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

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

Part I: Instructions for Preparing and Submitting an Application I-42

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 to

incorporate 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 to

agency 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 Identifier

Enter 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, not

the Federal agency.

3. Date Received by State and State Application Identifier

Enter 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 pre-

application number, if applicable. If this is a continuation, revision, or renewal application, enter the

assigned 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 the

previously 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:

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

Part I: Instructions for Preparing and Submitting an Application I-43

• 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 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/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 be

checked.

• 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 field

should remain blank

4.b. Agency Routing Identifier

Enter 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 DUNS Enter 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.

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

Part I: Instructions for Preparing and Submitting an Application I-44

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 Name Enter the legal name of the applicant which will undertake the assistance

activity, enter the complete address of the applicant (including

county/parish and country), and name, telephone number, e-mail, and

fax 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 undertake

the assistance activity.

Division Enter 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.

Street2 Enter 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.

State Enter the State where the applicant is located. This field is required if the

applicant is located in the United States.

Province Enter the Province.

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

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

ZIP Code Enter the nine-digit Postal Code (e.g., ZIP code) of applicant. This field

is 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 the

individual 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 this

section is identical to the AO profile information contained in the eRA Commons.

Field Name Instructions

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

Part I: Instructions for Preparing and Submitting an Application I-45

Field Name Instructions

Prefix The 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 Name Enter the first (given) name of the person to contact on matters related to

this application. This field is required.

Middle Name Enter the middle name of the person to contact on matters related to this

application.

Last Name Enter the last (family) name of the person to contact on matters related

to this application. This field is required.

Suffix Enter the suffix (e.g., Jr., Sr., Ph.D.) for the person to contact on matters

related to this application.

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

this application.

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 matters

related to this application. This field is optional.

City Enter the city of the person to contact on matters related to this

application. This field is required.

County/Parish Enter the county/parish of the person to contact on matters related to this

application.

State Enter the State where the applicant is located. This field is required if the

applicant is located in the United States.

Province Enter the Province.

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

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

ZIP Code Enter the nine-digit Postal Code (e.g., ZIP code) of applicant. This field

is required if the applicant is located in the United States. This field is

required if a State is selected; optional for Province.

Phone Number Enter the daytime phone number for the person to contact on matters

related to this application. This field is required

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

Part I: Instructions for Preparing and Submitting an Application I-46

Field Name Instructions

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

application.

Email Enter the e-mail address for the person to contact on matters related to

this 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, enter

all 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 that

is at least 51% owned by a woman or women, who also control and

operate 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 for

the first time.

• Resubmission: An application that has been previously

submitted, but was not funded, and is being resubmitted for

new consideration.

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

Part I: Instructions for Preparing and Submitting an Application I-47

Field Name Instructions

• Renewal: An application requesting additional funding for a

period subsequent to that provided by a current award. A

renewal application competes with all other applications and

must be developed as fully as though the applicant is

applying 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 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.

Existing definitions for NIH and other PHS agencies Type of

Application are somewhat different:

• New is the same. Check this option when submitting an

application 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 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/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 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 in

example 2 above) 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.

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

Part I: Instructions for Preparing and Submitting an Application I-48

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 the

previously assigned application/award number (e.g., use

CA987654 from 1R01CA987654-01A1).

If Revision, mark

appropriate 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.

In the field “Is this application being submitted to other

agencies?,” please check the box “yes” if one or more of the

specific aims submitted in your application are also contained in

a similar, identical, or essentially identical application submitted

to another Federal agency. Indicate the agency or agencies to

which 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 of

Applications Following RFA Review, and Submission of

Applications with a Changed Activity Code,

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-

100.html.

What Other Agencies? Enter Agency name.

9. Name of Federal Agency

Name the Federal agency from which assistance is being requested with this application. This field is pre-

populated from the opportunity package.

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

Part I: Instructions for Preparing and Submitting an Application I-49

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 is

requested. 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 Project

Enter 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 new

title.

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 Project

Start 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 district

code. For jurisdictions with no representative, enter “099”. For jurisdictions with a nonvoting

delegate, enter “098” for the district number. Example: DC-098, PR-098.

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

Part I: Instructions for Preparing and Submitting an Application I-50

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

Part I: Instructions for Preparing and Submitting an Application I-51

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 in

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

Field Name Instructions

Prefix The 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 Name Enter the first name of the PD/PI. This field is required.

Middle Name Enter the middle name of the PD/PI.

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

Suffix Enter 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 Name Enter 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.

Division Enter 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.

Street2 Enter 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.

State Enter the State where the PD/PI is located. This field is required if the

PD/PI is located in the United States.

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

Part I: Instructions for Preparing and Submitting an Application I-52

Field Name Instructions

Province Enter the province for PD/PI.

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

Country Select the country for the PD/PI address.

ZIP/Postal Code Enter 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 Number Enter the daytime phone number for the PD/PI. This field is required.

Fax Number Enter the fax number for the PD/PI.

E-mail Enter 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 unless

cost sharing is a requirement for the specific announcement.

c. Total Federal & Non-

Federal Funds

Enter total estimated funds for the entire project period, including both

Federal and non-Federal funds. This field is required.

For NIH and other PHS agencies applicants, this field will be the

same as Total Federal Funds Requested above unless the

specific announcement indicates that cost sharing is a

requirement.

d. Estimated Program

Income

Identify 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.

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

Part I: Instructions for Preparing and Submitting an Application I-53

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, and

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

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

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

award, debarment of individuals, as well as possible criminal penalties. The signer further

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

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

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

with any inappropriate or fraudulent conduct of the project activity.

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

Prefix Enter the prefix (Mr., Mrs., Rev.) for the name of the Authorized

Representative.

First Name Enter the first (given) name of the Authorized Representative. This field

is required.

Middle Name Enter the middle name of the Authorized Representative.

Last Name Enter the last (family) name of the Authorized Representative. This field

is required.

Suffix Enter 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.

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

Part I: Instructions for Preparing and Submitting an Application I-54

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.

Division Enter 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 Representative

in the “Street1” field. This field is required.

Street2 Enter 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 field

is required if the Authorized Representative is located in the United

States.

Province Enter 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 Code Enter 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 Number Enter the daytime phone number for the Authorized Representative. This

field is required.

Fax Number Enter the fax number for the Authorized Representative.

E-mail Enter 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

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

Part I: Instructions for Preparing and Submitting an Application I-55

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 the

announcement 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 the

following 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 specific

information 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 is

required explaining the reason for the Changed/Corrected Application. If you already

submitted 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

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

Part I: Instructions for Preparing and Submitting an Application I-56

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)].

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

Part I: Instructions for Preparing and Submitting an Application I-57

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 performed

at 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 off-

site in accordance with the conditions of the applicant organization’s negotiated Facilities and

Administrative (F&A) agreement. This information must agree with the F&A information on the

Cover Page Supplement Form of the application. If there is more than one performance site,

including any Department of Veterans Affairs (VA) facilities and foreign sites, list them in the

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

Part I: Instructions for Preparing and Submitting an Application I-58

fields provided for Location 1 - # below. Applicants should also provide an explanation of

resources available from each Project/Performance Site, the Facilities and Resources attachment

of 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 an

individual, and not on behalf of a company, state, local or tribal government, academia, or other

type 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 an

appropriate 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 other

sites(s), identify the site location(s) in the block(s) provided.

DUNS Number Enter the DUNS number associated with the organization where the

project 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 primary

performance site location. This field is required.

Street2 Enter second line of the street address in "Street 2" field for the primary

performance site location. This field is optional.

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

field is required.

County Enter 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..

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

Part I: Instructions for Preparing and Submitting an Application I-59

Field Name Instructions

Province Enter 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 field

is required.

ZIP Code Enter 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 of

Applicant” 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 with

no representative, enter “099”. For jurisdictions with a

nonvoting 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 other

sites(s), identify the site location(s) in the block(s) provided.

DUNS Number Enter the DUNS number associated with the organization where the

project will be performed. This field is optional.

Street1 Enter first line of the street address in "Street 1" field of the primary

performance site location. This field is required.

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

Part I: Instructions for Preparing and Submitting an Application I-60

Field Name Instructions

Street2 Enter second line of the street address in "Street 2" field for the primary

performance site location. This field is optional.

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

County Enter 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.

Province Enter 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 Code Enter the nine-digit Postal Code (e.g., ZIP code) of the primary

performance 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 of

Applicant” 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 with

no representative, enter “099”. For jurisdictions with a

nonvoting 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

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

Part I: Instructions for Preparing and Submitting an Application I-61

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 the

Protection 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.

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

Part I: Instructions for Preparing and Submitting an Application I-62

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 be

determined by an authority independent from the investigators

(http://answers.hhs.gov/ohrp/categories/1564

). Institutions often designate their IRB to make this

determination. Because NIH does not require IRB approval at the time of application, the

exemptions designated often represent the opinion of the PD/PI, and the justification provided for

the exemption by the PD/PI is evaluated during peer review.

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 be

designated 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 pre-

award cycle as a Just-In-Time

requirement.

Human Subject Assurance Number

Enter 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 8-

digit 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 signature

section on the SF424 (R&R) Cover form, is declaring that it will comply with 45 CFR part 46 and

proceed to obtain a human subjects assurances (see http://www.hhs.gov/ohrp

). Do not insert the

human 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.

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

Part I: Instructions for Preparing and Submitting an Application I-63

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 is

anticipated 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 of

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

application. However, this information is required under Just-In-Time Policy

Animal Welfare Assurance Number

Enter 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, disclosure

of which may harm the applicant, should be included in applications only when such information is

necessary to convey an understanding of the proposed project. If the application includes such

information, check yes and clearly mark each line or paragraph on the pages containing the

proprietary/privileged information with a legend similar to: "The following contains

proprietary/privileged information that (name of applicant) requests not be released to persons outside the

Government, except for purposes of review and evaluation. " This field is required.

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

Government shall have the right to use or disclose the information to the extent authorized by

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

the 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 Part 5). If an applicant fails to identify proprietary information at the

time of submission as instructed in the application guide, a significant substantive justification

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

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

Part I: Instructions for Preparing and Submitting an Application I-64

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 most

applicants 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 or

size than other actions included within a category.

2. The proposed research threatens to violate a Federal, State, or local law established for the

protection of the environment or for public health and safety.

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

4. Use of especially hazardous substances or processes is proposed for which adequate and

accepted controls and safeguards are unknown or not available.

5. The proposed research may overload existing waste treatment plants due to new loads

(volume, chemicals, toxicity, additional hazardous wasted, etc.)

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

7. The proposed research may introduce new sources of hazardous/toxic wastes or require

storage of wastes pending new technology for safe disposal.

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

9. Substantial and reasonable controversy exists about the environmental effects of the

proposed research.

4.a. Does the project have an actual or perceived impact—positive or negative—on the

environment?

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 been

authorized 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/No

If 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.

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

Part I: Instructions for Preparing and Submitting an Application I-65

5.a. If yes, please explain:

If you checked the Yes box indicating any performance site is designated, or eligible to be designated, as

a 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 with

international collaborators. Check yes or no. This field is required.

Applicants to NIH and other PHS agencies must check “Yes” if the applicant organization is a

foreign institution or if the project includes a foreign component. For a definition of a

foreign

component, 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 and

whether 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 of

objectives 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 and

specific aims, making reference to the health relatedness of the project (i.e., relevance to the

mission of the agency). Describe concisely the research design and methods for achieving the

stated 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 the

application will be accepted.

As noted above, do not include proprietary, confidential information or trade secrets in the

description 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.

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

Part I: Instructions for Preparing and Submitting an Application I-66

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 the

names of all authors (in the same sequence in which they appear in the publication), the article and

journal 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 a

document 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 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 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 the

effort proposed. Identify the facilities to be used (Laboratory, Animal, Computer, Office, Clinical and

Other). If appropriate, indicate their capacities, pertinent capabilities, relative proximity and extent of

availability 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 scientific

environment in which the research will be done contributes to the probability of success (e.g.,

institutional support, physical resources, and intellectual rapport). In describing the scientific

environment in which the work will be done, discuss ways in which the proposed studies will

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

Part I: Instructions for Preparing and Submitting an Application I-67

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 the

investigator, 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 and

pertinent capabilities. Please click the Add Attachment button to the right of this field to complete this

entry.

12. Other Attachments

Attach a file only to provide any other project information not provided above or in accordance with the

announcement and/or agency-specific instruction.

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

Part I: Instructions for Preparing and Submitting an Application I-68

4.5 Senior/Key Person Profile (Expanded) Form

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

Part I: Instructions for Preparing and Submitting an Application I-69

This form provides the ability to collect structured data for up to 100 senior/key persons. Data must be

entered 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 this

definition.

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, the

Contact PD/PI must be affiliated in the Commons with the applicant organization and should be

listed 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 “Co-

PD/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 Role

in 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

Prefix Pre-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.

Suffix Pre-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.

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

Part I: Instructions for Preparing and Submitting an Application I-70

Field Name Instructions

Department Pre-populated from the SF 424 (R&R). The name of primary

organizational 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 primary

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

Street1 Pre-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.

Street2 Pre-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 United

States.

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 United

States.

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.

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

Part I: Instructions for Preparing and Submitting an Application I-71

Field Name Instructions

E-mail Pre-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

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) for

anyone assigned the PD/PI role must be entered here and

must 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 project

role; e.g., Engineer, Chemist.

Degree Type Enter 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.

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

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

Part I: Instructions for Preparing and Submitting an Application I-72

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 person-

months 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 pre-

award cycle. When this occurs, you will be instructed to refer to

Other 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. While

alphabetical order is preferred, it is not required. However, be aware that these profiles will

appear 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 meet

the 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 compensation

is charged to the project.

After providing data for each individual senior/key person, click the Next Person button at the

bottom 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

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

Part I: Instructions for Preparing and Submitting an Application I-73

Field Name Instructions

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

Person.

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

required.

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

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

required.

Suffix Enter 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 Name Enter the name of organization of the Senior/Key Person.

This is a required field for applications submitted to NIH and

other PHS agencies.

Division Enter 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.

Street2 Enter 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.

State Enter the State where the Senior/Key Person is located. This field is

required if the senior/key person is located in the United States.

Province Enter 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.

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

Part I: Instructions for Preparing and Submitting an Application I-74

Field Name Instructions

ZIP Code Enter 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 Number Enter the daytime telephone number for the Senior/Key Person. This field

is required.

Fax Number Enter the fax number for the Senior/Key Person.

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

for the Senior/Key Person.

Credential, e.g., agency

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) for

anyone assigned the PD/PI role must be entered here and

must 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” 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. If applicants wish to

use a different role, select “Other” for the Project Role field and

then 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 other

senior/key persons have been listed.

Other Project Role

sponsored 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 of

modules. See:

http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-

02-017.html

Save the information in a single file and click the add attachment button

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

Part I: Instructions for Preparing and Submitting an Application I-108

Field Name Instructions

to complete this entry.

Consortium Justification Provide an estimate of total costs (direct plus Facilities and

Administrative) for each year, rounded to the nearest $1,000. List the

individuals/ organizations with whom consortium or contractual

arrangements have been made. List all personnel, including percent of

effort and roles on the project. No individual salary information should be

provided. Indicate whether the collaborating institution is foreign or

domestic. 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 the

overall 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, and

then click Open.

Additional Narrative

Justification

If the requested budget requires any additional justification; e.g, variations

in the number of modules requested, save the information in a single file

and 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.

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

Part I: Instructions for Preparing and Submitting an Application I-109

5.5 PHS 398 Research Plan Form

The Research Plan should include sufficient information needed for evaluation of the project, independent

of 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 system-

generated 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.

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

Part I: Instructions for Preparing and Submitting an Application I-110

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 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 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 the

application 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/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 information

that constitutes trade secrets, or information that is commercial or financial, or information that is

confidential or privileged, make sure you have checked “Yes” for the proprietary/privileged information

question in the Other Project Information form.

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

Part I: Instructions for Preparing and Submitting an Application I-111

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 confidence

with the understanding that the information shall be used or disclosed only for evaluation of this

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

application, the Government shall have the right to use or disclose the information to the extent

authorized by law. This restriction does not limit the Government’s right to use the information if it is

obtained 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 Part

5). If an applicant fails to identify proprietary information at the time of submission as instructed in the

application 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, Specific

Aims, Research Strategy, etc).

Field Name Instructions

1. Introduction to

Application (for

Resubmission or Revision

only)

Use only if Type of Application is Resubmission or Revision. See specific

instructions 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 and

Revisions. Follow the page limits for the Research Strategy 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.

2. Specific Aims State concisely the goals of the proposed research and summarize the

expected outcome(s), including the impact that the results of the proposed

research will exert on the research field(s) involved.

List succinctly the specific objectives of the research proposed, e.g., to

test a stated hypothesis, create a novel design, solve a specific problem,

challenge an existing paradigm or clinical practice, address a critical

barrier to progress in the field, or develop new technology.

The Specific Aims attachment is required unless otherwise specified in

the FOA. Follow the page limits for the Research Strategy 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.

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 published

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

Part I: Instructions for Preparing and Submitting an Application I-112

Field Name Instructions

experimental details in the Research Strategy section and provide the full

reference 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 to

progress in the field that the proposed project addresses.

• Explain how the proposed project will improve scientific

knowledge, 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 applications

of theoretical concepts, approaches or methodologies,

instrumentation, or interventions.

• Describe the overall strategy, methodology, and analyses to

be used to accomplish the specific aims of the project. Unless

addressed separately the Resource Sharing Plan, attachment

include how the data will be collected, analyzed, and

interpreted as well as any resource sharing plans as

appropriate.

• Discuss potential problems, alternative strategies, and

benchmarks 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 be

hazardous to personnel and precautions to be exercised. A full

discussion on the use of select agents should appear in the

Select Agent Research attachment, below.

• If research on Human Embryonic Stem Cells (hESCs) is

proposed but an approved cell line from the NIH hESC

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

Part I: Instructions for Preparing and Submitting an Application I-113

Field Name Instructions

Registry cannot be identified, provide a strong justification

for why an appropriate cell line cannot be chosen from the

Registry 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 grant

application 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 less

emphasis on the preliminary data in application from Early Stage

Investigators than on the preliminary data in applications from more

established investigators).

Progress Report for Renewal and Revision Applications. For

renewal/revision applications, provide a Progress Report. Provide the

beginning and ending dates for the period covered since the last

competitive 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 the

specific aims and any new directions including changes to the specific

aims 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, and

then 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 Access

Policy, were authored or co-authored by the applicant and arose from NIH

support, provide the NIH Manuscript Submission reference number (e.g.,

NIHMS97531) or the PubMed Central (PMC) reference number (e.g.,

PMCID234567) for each article. If the PMCID is not yet available

because the Journal submits articles directly to PMC on behalf of their

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

Part I: Instructions for Preparing and Submitting an Application I-114

Field Name Instructions

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

these 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 human

subjects involved?” on the R&R Other Project Information Form. If you

answered “no” to the question but your proposed research involves human

specimens and/or data from subjects you must provide a justification in

this section or your claim that no human subjects are involved. Follow the

instructions provided in the Application Guide and the FOA regarding the

Protection of Human Subject attachment.

Do not use the protection of human subjects 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, and

then click Open.

6. Inclusion of Women and

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, and

then 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 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, and

then click Open.

Other Research Plan Sections

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

Part I: Instructions for Preparing and Submitting an Application I-115

Field Name Instructions

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 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 to address the following five points will result in the

application being designated as incomplete and will be grounds for the PHS to

defer the application 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 and indicate

when it is anticipated that animals will be used. If an award is made, 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 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 and numbers.

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 conduct of

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 the

recommendations 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

Do not use the vertebrate animal section to circumvent the page limits of the

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

Part I: Instructions for Preparing and Submitting an Application I-116

Field Name Instructions

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 click

Open.

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 maintain

a list of these agents. See http://www.selectagents.gov/

If the activities proposed in the application involve only the use of a strain(s) of

select agents which has been excluded from the list of select agents and toxins

as per 42 CFR 73.3, the select agent requirements do not apply. Use this 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 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 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 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 the

name(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, and

security of the select agent(s).

• Describe the biocontainment resources available at all performance

sites.

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

Part I: Instructions for Preparing and Submitting an Application I-117

Field Name Instructions

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 any

questions 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.

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 at

organizations other than the applicant organization. A rationale for choosing a

multiple PD/PI approach should be described. The governance and

organizational structure of the leadership team and the research project should

be described, including communication plans, process for making decisions on

scientific direction, and procedures for resolving conflicts. The roles and

administrative, technical, and scientific responsibilities for the project or

program should be delineated for the PD/PIs and other collaborators. 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 of

the 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 a

footnote on the Notice of Grant 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.

11.

Consortium/Contract

ual Arrangements

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

between the applicant organization and the consortium organization(s). If

consortium/contractual activities represent a significant portion of the overall

project, explain why the applicant organization, rather than the ultimate

performer of the activities, should be the grantee. The signature of the

Authorized Organization Representative on the SF424 (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 of each

organization involved in this grant application are aware of the

agency’s consortium agreement policy and are prepared to establish the

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

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.

12. Letters of Support

(e.g., Consultants)

Provide all appropriate letters of support, including any letters necessary to

demonstrate the support of consortium participants and collaborators such as

Senior/Key Personnel and Other Significant Contributors included in the grant

application. Letters are not required for personnel (such as research assistants)

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

Part I: Instructions for Preparing and Submitting an Application I-118

Field Name Instructions

not contributing in a substantive, measurable way to the scientific development

or execution of the project. Letters should stipulate expectations for co-

authorship, and whether cell lines, samples or other resources promised in the

letter are freely available to other investigators in the scientific community or

will be provided to the particular investigators only. For consultants, letters

should include rate/charge for consulting services and level of effort/number of

hours per year anticipated. In addition, letters ensuring access to core facilities

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

service. Do not place these letters in the Appendix. Consultant biographical

sketches 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 click

Open.

13. 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 been developed with NIH

funds and the associated research findings published or provided to NIH, it is

important that they be made readily available for research purposes to qualified

individuals within the scientific community. See 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 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 the specific opportunity carefully and

discuss their data-sharing plan with their program contact at the time they

negotiate an agreement with the Institute/Center (IC) staff to accept assignment

of their application. See Data-Sharing Policy

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

2. Sharing Model Organisms: Regardless of the amount requested, all

applications where the development of model organisms is anticipated are

expected to include a description of a specific plan for sharing and distributing

unique model organisms or state why such sharing is restricted or not possible.

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/.

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

Part I: Instructions for Preparing and Submitting an Application I-119

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, and then click

Open.

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, please

refer 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 order

attached, so it is important to use filenames for attachments that are descriptive

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 the

following 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 3

of the following types of publications:

o Manuscripts and/or abstracts accepted for publication but

not yet published: The entire article should be submitted as a

PDF attachment.

o 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.

o 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 be

submitted in the Appendix as necessary.

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

Part I: Instructions for Preparing and Submitting an Application I-120

Field Name Instructions

• 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 no

longer 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 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.

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.

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

Part I: Instructions for Preparing and Submitting an Application I-121

5.8.1 Planned Enrollment Report

Field Name Instructions

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

Part I: Instructions for Preparing and Submitting an Application I-122

Field Name Instructions

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 and

the 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

Native

Enter 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.

Asian Enter 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 Islander

Enter 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 the

respective 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 and

Hispanic or Latino. These are required fields.

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

Part I: Instructions for Preparing and Submitting an Application I-123

Field Name Instructions

More than One Race Enter 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 the

respective 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 of

both Not Hispanic or Latino and Hispanic or Latino ethnicity in each

racial category.

5.8.2 Cumulative Inclusion Enrollment Report

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

Part I: Instructions for Preparing and Submitting an Application I-124

Field Name Instructions

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 original

Planned Enrollment form for this study. Follow the instructions provided

in the Application Guide and the FOA regarding the Inclusion of Women

and 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

Native

Enter 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 number

of females, males, and individuals of unknown/not reported sex/gender (in

the respective fields) who are American Indian/Alaska Native 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 American Indian/Alaska Native and of unknown/not reported

ethnicity. These are required fields.

Asian Enter 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, and

individuals 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 the

respective fields) who are Asian and of unknown/not reported ethnicity.

These are required fields.

Native Hawaiian or Other

Pacific Islander

Enter 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 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 Hispanic or Latino; and enter 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 of unknown/not

reported ethnicity. These are required fields.

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

Part I: Instructions for Preparing and Submitting an Application I-125

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 the

respective 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 Black

or 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, and

individuals 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 the

respective fields) who are White and of unknown/not reported ethnicity.

These are required fields.

More than One Race Enter 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 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 Hispanic or Latino; and enter 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 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 of

females, males, and individuals of unknown/not reported sex/gender (in

the respective fields) whose race is unknown/not reported and who are

Hispanic or Latino; and enter the number of females, males, and

individuals 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 for

females, males, and individuals of unknown/not reported sex/gender who

are Hispanic or Latino, and all racial categories for females, males, and

individuals 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.

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

Part I: Instructions for Preparing and Submitting an Application I-126

6. Peer Review Process

Overview

NIH policy is intended to ensure that applications for funding submitted to the NIH are evaluated on the

basis 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 and

Research 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 non-

federal 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 the

NIH Institute or Center may make funding decisions.

NIH has implemented Special Council Review procedures for the additional review of grant and

cooperative 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 the

better 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 the

reviewers 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 (see

below). 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.

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

Part I: Instructions for Preparing and Submitting an Application I-127

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 than

an arithmetic formula applied to the reviewer’s scores given to each criterion. The final impact score for

each 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 stated

otherwise in the FOA, the Summary Statement represents a combination of the reviewers' written

comments 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 administrative

notes 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 the

Summary 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, in

consideration 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 the

determination of scientific and technical merit, and give a separate score for each. An application does not

need to be strong in all categories to be judged likely to have major scientific impact. For example, a

project 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 the

field? 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 the

concepts, methods, technologies, treatments, services, or preventative interventions that drive this

field?

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 record

of 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 practice

paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or

interventions? 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 to

accomplish the specific aims of the project? Are potential problems, alternative strategies, and

benchmarks for success presented? If the project is in the early stages of development, will the

strategy establish feasibility and will particularly risky aspects be managed?

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

Part I: Instructions for Preparing and Submitting an Application I-128

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) of

individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of

children, 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 the

probability 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 unique

features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria. As applicable for the project proposed, reviewers will consider the

following 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 for

inclusion 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 from

research 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 the

inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and

research strategy proposed. For additional information see the

Human Subjects Protection and

Inclusion Guidelines.

Vertebrate animals: The committee will evaluate the involvement of live vertebrate animals as part

of 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 and

for 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 potentially

hazardous to research personnel and/or the environment, and if needed, determine whether adequate

protection is proposed.

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

Part I: Instructions for Preparing and Submitting an Application I-129

Resubmission Applications: When reviewing a Resubmission application the committee will

evaluate the application as now presented, taking into consideration the response to comments from

the 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 the

appropriateness 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 not

recommended 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 each

of 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 the

application, 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/notice-

files/NOT-OD-07-088.html).

Budget and Period of Support. Reviewers will consider whether the budget and the requested period

of support are fully justified and reasonable in relation to the proposed research

Dual-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 and

cooperative 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

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

Part I: Instructions for Preparing and Submitting an Application I-130

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 need

for 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 specific

information associated with the award mechanism and includes names of individuals that may be

contacted 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 is

strongly 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 for

various career award opportunities are issued periodically in the NIH Guide for Grants and Contracts, a

weekly 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 for

these 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 this

information is subject to change, prospective applicants are encouraged to review the K-Kiosk

for the

most current program information. The K-Kiosk includes information on NIH-wide Parent FOAs as well

as IC-specific FOAs for a particular K program.

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

Part I: Instructions for Preparing and Submitting an Application I-131

Summary of Research Career Development Award Programs

PROGRAM

DESCRIPTION MENTOR

REFERENCE

LETTERS

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 electronically

through 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 letters

should be from individuals not directly involved in the application, but who are familiar with the

applicant’s qualifications, training, and interests. The mentor/co-mentor(s) of the application cannot be

counted 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, and

institution) 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 the

SF424 (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 can

make 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 the

candidate's current department or organization, but are knowledgeable about their qualifications, should

be selected.

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

Part I: Instructions for Preparing and Submitting an Application I-132

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

NOT-

OD-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 application

electronically. 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, a

confirmation number, and the date the letter was submitted.

The candidate may check the status of submitted letters by logging into their Commons account and

accessing the “check status” screen for this application. The candidate is responsible for reviewing the

status of submitted reference letters and contacting referees to ensure that letters are submitted by the

receipt 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 to

develop the research capabilities and career of the candidate. These awards provide salary support and

guarantee them the ability to devote at least 9 person months (75% of their total professional effort) to

research for the duration of the award. Many of these awards also provide funds for research and career

development 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 career

development award program for which support is being requested. This should include your evaluation

with special reference to:

• potential to become an independent research scientist;

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

Part I: Instructions for Preparing and Submitting an Application I-133

• 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 by

e-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 letters

themselves. 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.

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

Part I: Instructions for Preparing and Submitting an Application I-134

7.4 K- Specific Instructions for K 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.

7.4.1 Special Instructions for 4.2 Cover Form

Type of Application: Unless stated in the applicable FOA, individual K awards are usually not

renewable 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 the

individual candidate (considered the PD/PI for K award programs). If the candidate is not located at the

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

candidate can be reached prior to the requested award start date. If the PD/PI is not located at the

applicant organization at the time of submission, the Commons account for the PD/PI must be affiliated

with the applicant organization. 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 be

shared with peer reviewers. For mentored CDA applications, the cover letter must contain the same list of

Referees (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

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

Part I: Instructions for Preparing and Submitting an Application I-135

information provided is of major importance in establishing the feasibility of the goals of the career

development 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 registration

in 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 biosketch

in 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 the

baccalaureate 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 location

of the institution;, the degree 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. 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.

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

Part I: Instructions for Preparing and Submitting an Application I-136

Honors

List 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 the

last 10 years, giving dates. Include present membership on any Federal Government public advisory

committee.

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:

o Original research and theoretical treatises;

o Non-experimental articles, e.g., review of literature in field, book chapters, etc.;

o Books, 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 in

any 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 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 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.)

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 the research proposed in this

application. 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 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 research team. In contrast, “Other

Support” information is required for all applications that are selected to receive grant awards. NIH staff

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

Part I: Instructions for Preparing and Submitting an Application I-137

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 and

contributors. All individuals who have committed to contribute to the scientific development and

execution 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 co-

mentors should be assigned the Project Role of “Other Professional” and then enter “Mentor” or “Co-

mentor” 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 for

the 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’s

current 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-Time

basis.

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 a

pending 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 biographical

sketch for all individuals other than the candidate, follow the biographical sketch instructions found in

Part I.4.5.

Note: K22 and K99/R00 candidates should follow instruction in the specific FOA regarding senior/key

personnel.

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

Part I: Instructions for Preparing and Submitting an Application I-138

7.4.5 Special Instructions for 4.6 Selecting the Appropriate Budget

Form

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 are

advised to contact the targeted awarding component if uncertain about allowable amounts for the

applicable 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 are

negotiated with the sponsoring intramural laboratory. For awardees who receive approval to transition to

the extramural phase, a budget will be required as part of the extramural sponsored application.

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 research

development support being requested for the initial year of the K award. Usually, a specific total amount

is allowed for research development and other costs (tuition, fees, research supplies, equipment, computer

time, travel, etc) that do not require individual cost category identification. Unless instructed differently in

the applicable FOA, applicants should enter only the total requested research development support

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-to-

system 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 of

a negotiated rate agreement. Follow the instructions in the chart below for completing this section.

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

Part I: Instructions for Preparing and Submitting an Application I-139

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 name

of the cognizant Federal agency, name, and phone number of the

individual responsible for negotiating your rate. Either response is

acceptable since indirect costs will be reimbursed as 8% of modified total

direct costs rather than on the basis of a negotiated rate agreement.

4.7.3.K Budget Justification: Use this to provide a detailed description and justification for specific

items within the Research Development Support costs; e.g., all equipment, supplies, and other personnel

that will be used to help achieve the career development and research objectives of this award.

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 data

required 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 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) 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.

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

Part I: Instructions for Preparing and Submitting an Application I-140

7.5 PHS 398 Career Development Award Supplemental Form

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

Part I: Instructions for Preparing and Submitting an Application I-141

The PHS 398 Career Development Award Supplemental Form should include sufficient information

needed 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 for

sections that, when combined, must fit within a specified limitation.