# Presentation: 722845

## A Walk Through The SF424 (R&R)

- Marcia Hahn
- Office of Policy for Extramural Research Administration, OER, NIH
- January 11, 2006

## Handouts for This Session

**A Walk Through The SF424 (R&R)** (*Powerpoint Presentation Slides*)
**Sample Application Package** (*PDF sample of all the SF424 (R&R) components + agency-specific components)*
**eRA Assembly of the SF424 (R&R)** **Application**** **(*Word document showing system-generated Table of Contents + a chart referencing where each piece of the TOC is found in the (R&R))*

## Features of the SF424 (R&R)

- The SF424 (R&R) is an application form that is comprised of common data elements developed for use by Federal agencies funding _**R**_esearch and _**R**_esearch-Related programs
- Also provides a consistent electronic submission process through Grants.gov

**Notes:**
“Data Set”  used because many Institutions will use System-to-system

## Features of the SF424 (R&R) (cont.)

- SF424 (R&R) data is arranged in components
- Not all components will be used for every Funding Opportunity Announcement (FOA)
- Agencies “construct” application packages for each FOA
- NIH will use several “standard” packages
- The FOA will indicate which components are required and which are optional
- Each FOA will have the appropriate application package attached
- A direct link is provided on each FOA in the NIH Guide:

**Notes:**
Example:  NIH will never use the Personal Data Component  (Commons registration makes this component unnecessary)
Standard Packages:  SBIRs/STTRs—SBIR Component unique only to these mechanisms

## Features of the SF424 (R&R) (cont.)

- A complete application to NIH will include a combination of (R&R) components & PHS398 components
- The applicant **must** complete the application using the package attached to that particular FOA  (*Information is drawn from the specific FOA and used in the forms)*
- Applicants can *not* use any sample form packages or form packages from other announcements
- The applicant will complete data entry in all necessary components and upload appropriate attachments

## Features of the SF424 (R&R) (cont.)

- SF424 (R&R) Components include:
- SF424 (R&R)—*An application cover component*
- Research & Related Project/Performance Site Location (s)
- Research & Related Other Project Information
- Research & Related Senior/Key Person
- Research & Related Budget
- Research & Related Personal Data *(NIH will not use)*
- R&R Subaward Budget Attachment Form
- SBIR/STTR Information

## Features of the SF424 (R&R) (cont.)

- NIH requires additional data collection to accommodate the unique information required for review of its biomedical research portfolio.  Therefore, NIH has also developed agency-specific components (titled PHS398):
- PHS398 Cover Letter File
- PSH398 Cover Page Supplement *(supplements the R&R Cover)*
- PHS 398 Modular Budget
- PHS 398 Research Plan
- PHS 398 Checklist
- Why call them PHS398?
- Needed a generic term since other HHS agencies will use
- It’s the OMB-cleared data collection instrument that gives us the authority to request these additional data elements

## Features of the SF424 (R&R) (cont.)

- Application components include specific data fields as well as multiple attachments
- Most attachments are text
- NIH requires PDF for text attachments
- Attachments can be generated using any word processing software but will need to be converted to PDF before they can be attached to the actual application form
*(Applicants will need some type of PDF-creation software)*

## Features of the SF424 (R&R) (cont.)

- After submission, the **eRA system** will:
- Generate a Table of Contents
- Assemble the grant image
- Include headers (PI name) & footers (page numbers) on all pages
- Applicants (*PD/PI & Authorized Organizational Representative)* will review and verify this grant image in the eRA Commons

## Features of the SF424 (R&R):  Application Guide

- NIH has developed 2 Application Guides specific to the SF424 (R&R):  1) General Instructions; 2) General +SBIR/STTR
- Includes instructions that are imbedded in the actual forms as well agency-specific instructions
- Agency-specific instructions denoted with the HHS Logo
- Documents have same part structure as PHS 398 Instructions:
- Part I:  Instructions for Preparing and Submitting an Application
- Part II:  Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan
- Part III:  Policies, Assurances, Definitions

## SF424 (R&R) Components

- Application Package Header
- SF424 (R&R)—*An application cover component*
- Research & Related Project/Performance Site Location (s)
- Research & Related Other Project Information
- Research & Related Senior/Key Person
- Research & Related Budget
- R&R Subaward Budget Attachment Form
- SBIR/STTR Information

## Header Information 

- Header Information
- Pre-filled from announcement

## Slide 13

## Features of the SF424 (R&R):Application Package Header

- Header page is attached to every posted application package
- Header data is pre-filled from the actual announcement
- Notes which components are requires (mandatory) and which are optional for this particular announcement
- Includes basic instructions
- Includes Application Submission  Verification & Signature screen

## Features of the SF424 (R&R):Application Package Header (cont)

**Multiple CFDA Issue**
- For FOAs posted before 12/19/2005, the system draws only the first CFDA in the list
- For FOAs posted after 12/19/2005, the system now leaves this field blank
- For either situation, applicants should just ignore this and not try to enter/change data
- In Grants.gov, use the FOA number for searching and confirming you are responding to the correct announcement
- Or use the link directly from the NIH Guide FOA

## Features of the SF424 (R&R):Application Package Header (cont)

**Saving an application package**:  You will get warning message when you first save a package from the FOA.  This is because no data has been entered yet.  Users will continue to get this message each time you save until all data is entered.  OK to ignore message.  Just prior to submission recommend using the “Check Package for Errors”

## SF424 (R&R) 

**SF424 (R&R) **
**Cover Component**
**Page 1**

## SF424 (R&R) 

**SF424 (R&R) **
**Cover Component**
**Page 2**

## Component: SF424 (R&R)—A Cover Component

- Similar to the PHS398 Face Page
- Provides general information about the applicant organization, contact information for the PD/PI and Authorized Organizational Representative
- Provides application-specific information (type, title etc)

**Notes:**
As you familiarize yourself with the forms, use the Application Guide.  Many agency-specific instructions have been added to provide clarity for some data elements

## SF424 (R&R)—A Cover Component: A Few Data Issues 

**Item 1, Type of Submission**
- Pre-application—instructed not to use unless specifically noted in FOA
- Changed/Corrected Application—To be used only when correcting an application that failed system validations.  This is NOT a resubmission (amendment).
**Item 5, Applicant Information**:  This is for the applicant ***organization***
**Organizational DUNS*****:  ***Must match DUNS in eRA Commons profile for Applicant Institution
- AOR should verify DUNS in Commons profile before submission

## SF424 (R&R)—A Cover Component: A Few Data Issues

**Item 8, Type of** **Application--**New Terminology
- New is the same
- Resubmission is equivalent to a Revision (*a revised or amended application) *
- Renewal is equivalent to a Competing Continuation
- Continuation is equivalent to a 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 a Competing Supplement
- Terminology cross-walk provided in instructions

## SF424 (R&R)—A Cover Component: A Few Data Issues

**Item 10, CFDA Number & Title**
*CFDA = Catalog of Federal Domestic Assistance*
- Fields are pre-filled based on the specific announcement
- Fields may be blank for applications in response to a FOA that include multiple CFDAs
- When multiple CFDAs are listed in an announcement, a CFDA will be assigned by the eRA system once a specific Institute assignment is made

## Project/Performance Site Locations

**Project/Performance Site Locations**

## Component: Research and Related Project/Performance Site Locations

- Equivalent to the PHS398 Form Page 2 Performance Site section
- Collects individual data for up to 8 locations
- > 8 locations information is provided in an attachment (*not structured data, just text*)
- Format for the >8 attachment available on SF424 (R&R) Forms Page: _[http://grants.nih.gov/grants/funding/424/index.htm](http://grants.nih.gov/grants/funding/424/index.htm)_

## Other Project Information

**Other Project Information**

## Component: Research and Related Other Project Information

- Includes information on involvement of Human Subjects, Vertebrate Animals, Environmental Impact, Foreign Involvement
- Includes separate PDF attachments for
- Project Summary/Abstract
- Project Narrative
*NIH will use this upload for the “Relevance” section of the Abstract*
*Separate component developed for Research Plan*
- Bibliography & References (*previously section G. Literature cited*)
- Facilities & Other Resources
- Equipment resources

*Equivalent to PHS 398 Resources Format Page*

## Senior/Key Person Profile

**Senior/Key Person Profile**

## Component: Research and Related Senior/Key Person

- Captures personal profile information on the PD/PI, Key Personnel, and Other Significant Contributors
- Captures structured data for 8 individuals (PI and 7 others)
- > 8 information is provided in an attachment (*not structured data, just text*)
- Format for the >8 attachment available on SF424 (R&R) Forms Page: _[http://grants.nih.gov/grants/funding/424/index.htm](http://grants.nih.gov/grants/funding/424/index.htm)_

## Component: Research and Related Senior/Key Person (cont.)

**Credential**:  Must enter the eRA Commons User Name—For the PD/PI, this is a **mandatory** field for NIH submissions.  (*#1 Validation Failure to date)*
- Biosketch is attached for each person
*Same data requirements exist; however, page limits slightly change to just 4 pages*
*Eliminating the 2 page limit for subsections*
- Note, Attachment for Current & Pending Support (*a.k.a. Other Support*) will not be used at time of submission unless specified in FOA.  For most applications, this will continue to be a Just-In-Time submission

## R&R Budget Sections A & B

**R&R Budget Sections A & B**

## Component: Research and Related Budget, Sections A & B

- Personnel separated into 2 sections
- A.  Senior/Key Person
- Allows 8 as named individuals & structured data
- > 8 information is provided in an attachment (*not structured data, just text*)
- Info for PD/PI must be entered even if $ = 0
- B.  Other Personnel
- Postdocs, Grad Students, Undergrads:  captures # only
*NIH will request more detail in Budget Justification*
**Business Process Change from Percent Effort to Person Months**
- NIH will be incorporating this business process change throughout-- Other Support documentation; Interim change to PHS398 & PHS2590 Progress Report in process

## R&R Budget

**R&R Budget**
**Sections C - E**

## Component: Research and Related Budget, Sections C - E

- C. Equipment
- Allows itemization of up to 10
- > 10 total dollars are inserted in line 11; however, the details are provided in an attachment
- D. Travel
- R&R separates out Domestic & Foreign
- This will not change any NIH policy/practice.  We will continue to award as a single category
- E. Participant/Trainee Support Costs
- Will not be used by NIH unless specifically noted in an announcement
- Tuition Remission will continue to included in section F. Other Direct Costs

## R&R Budget

**R&R Budget**
**Sections F - K**

## Component: Research and Related Budget, Sections F - K

- F. Other Direct Costs
- Itemizes Supplies, Publication Costs, Consultants, ADP/Computer Services, Consortium Costs, Equipment or Facility Rental/User Fees, Alterations & Renovations
- Have included agency-specific instructions to use this section to also account for patient care costs & tuition remission
- G. Total Direct Costs (A – F)
- H. Indirect Costs
- I. Total Costs
- J. Fee
- K.  Budget Justification—a PDF text attachment
*Next Period* Button:  At the top of the last budget page.  All required data field in this component must be entered before this button is available

## Component: Research and Related Budget, General Notes

- Applicant prepares a detailed budget for *every* budget period
*There is no summary budget page like the PHS398 Form Page 5*
- A detailed Cumulative budget is system-generated

## Slide 37

## Component: R&R Subaward Budget Attachment Form

- Used for detailed budget from any consortium grantee
- Allows up to 10 separate budget attachments—one for each consortium grantee
- Applicant sends the R&R budget component to the consortium grantee for completion; it is returned to the applicant; applicant attaches it in this component
- Applicant still needs to include the total costs for all consortiums in their own detailed budget, Section F.5

## SBIR/STTR Information

**Page 1**

## SBIR/STTR Information

**Page 2**

## Component: SBIR/STTR Information

- Includes eligibility questions answered by both SBIR & STTR applicants as well as separate sections for SBIR & STTR-specific questions
- Includes Commercialization Plan as PDF Attachment

## Agency-specific Components (a.k.a. PHS 398 Components)

- PHS398 Cover Letter File
- PSH398 Cover Page Supplement *(supplements the R&R Cover)*
- PHS 398 Modular Budget
- PHS 398 Research Plan
- PHS 398 Checklist

## Slide 43

## Component: PHS 398 Cover Letter

- Provides a text attachment for a cover letter
- Instructions to applicant remain the same as in the PHS398
- Will be stored separately in the eRA Grant Folder, not as a part of the main application grant image
- Will be seen only by appropriate NIH staff; not peer reviewers
- Required when submitting a Changed/Corrected Application
- If *revising* the cover letter for a Changed/Corrected application, include all previous submitted letter text

## PHS 398 

**PHS 398 **
**Cover Page Supplement **
**Page 1**

## PHS 398

**PHS 398**
**Cover Page Supplement **
**Page 2**

## Component: PHS 398 Cover Page Supplement

- Companion form to the (R&R) Cover Component
- For the PI, includes New Investigator Code & Degree fields (*Note, PD/PI info at the top is pre-filled. Provided here for reference only*)
- Includes Clinical Trial & Phase-III defined clinical trial indicators
- For the Business Official Contact, includes complete contact information (*title & mailing address missing from section 5 of the R&R Cover)*
- Includes Human Embryonic Stem Cells section

## PHS 398 Modular Budget

**PHS 398 Modular Budget**

## Component: PHS 398 Modular Budget

- Provides data entry for each budget period for
- A.  Direct Costs
- DC less consortium F&A
- Consortium F&A
- Total DC
- B. Indirect Costs Calculation section
- C. Total Costs (A + B)
- Cumulative Budget is system-generated
- Budget Justification PDF text attachments for Personnel, Consortium and Other

## PHS 398 Research Plan

**PHS 398 Research Plan**

## Component: PHS 398 Research Plan

- Separate PDF attachments for each section (*designed to maximize benefits of system validations*)
- For each, include a section heading as part of the text; i.e., Specific Aims, Background & Significance
- Same formatting requirements in the PHS398 continue here—margins, page limits, etc
- Appendix Material
- Allows up to 10 separate attachments
- Will be stored separately in the eRA Grant Folder, not as a part of the main application grant image
- Will be accessible to appropriate NIH staff and peer reviewers

## PHS398

**PHS398**
**Checklist Page 1**

## PHS398

**PHS398**
**Checklist**
**Page 2**

## Component: PHS 398 Checklist

- Captures additional information currently captured in the PHS398 Checklist
- Change of PI
- Change of Grantee Institution
- Inventions & Patents
- Program Income
- PDF Text Upload for and Assurances/Certifications explanation

## What will a completed application look like?

- After submission, the **eRA system** will:
- Assemble the grant image
- Generate a Table of Contents
- Include headers (PI name) & footers (page numbers) on all pages
*“**eRA Assembly of Grant Application”* is found at: _[http://grants.nih.gov/grants/funding/424/index.htm](http://grants.nih.gov/grants/funding/424/index.htm)__  _
- (*A document providing a sample Table of Contents & a chart cross-referencing the location in the forms components for each piece of the grant image*)

## 424 R&R and PHS-398 Specific

**Table of Contents**
**	****	****	****	****	****	****	****	****	****	**
***	******	******	******	******	******	******	******Page Numbers***
**SF 424 R&R Face Page****	****	****	****	**	________	_1_
**Table of Contents****	****	****	****	****	**	_	__3_
**Research & Related Project/Performance Site Location(s)****	****_________**
**	**Additional Locations					_________
**Research & Related Other Project Information****	****	**	_________
- 	Project Summary/Abstract (Description)			_________
- 	Public Health Relevance Statement			_________	Bibliography & References Cited			_	____
- 	Facilities & Other Resources				_	____
- 	Equipment
**Research & Related Senior/Key Person****	****	****	**_	____
- Biographical Sketches for each listed Senior/Key Person		_	____
- 	Additional Senior/Key Person Profiles			_	____
- 	Additional Biographical Sketches			_________
**Research & Related Budget – Year 1****	****	**		_	____
**Research & Related Budget – Year 2****	**			_	____
**Research & Related Budget – Year 3****	**			_	____
**Research & Related Budget – Year 4****	**			_	____
**Research & Related Budget – Year 5****	**			_	____
**Research & Related Budget – Cumulative Budget****	****	****_________**
**Research & Related Consortium Budget****	****	****	**_	____

## SBIR/STTR Information					

- 	Research & Development Outside the U.S.** **		_	_
- 	Commercialization Plan				_	_
- 	Prior SBIR Phase II Awards			**	**_	_
**PHS 398 Specific Cover Page Supplement****	****	**		_**	**_
**PHS 398 Specific Modular Budget****	****	****	**	_**	**_
**	**Personnel Justification				_	_
- 	Consortium Justification				_	_
- 	Additional Narrative Justification				_	_
**PHS 398 Specific Research Plan****	****	****	**	_	_
**	**Introduction to Application				_	_
- 	Specific Aims				_	_
- 	Background and Significance				_	_
- 	Preliminary Studies/Progress Report				_	_
- 	Research Design and Methods				_	_
- 	Human Subjects Sections				_	_
- 	           Protection of Human Subjects				_	_
- 	           Data and Safety Monitoring Plan	** **		_	_
- 	           Inclusion of Women and Minorities		_	_
- 	           Targeted/Planned Enrollment Table		_	_
- 	            Inclusion of Children				_	_
**	**Vertebrate Animals				_	_
- 	Consortium/Contractual Arrangements 			_	_
- 	Resource Sharing Plan				_	_
- 	Letters of Support				_	_
**PHS 398 Checklist****	****	****	**	_	_
**	**PHS 398 Specific Assurances/Certification Explanation	_	_
**Appendix****	****	****	****	**_**	**_

## New Terminology:Type of Application

| NIH Term | (R&R) Term |
| --- | --- |
| New (T-1) | New |
| Competing Continuation (T-2) | Renewal |
| Revision or Amendment | Resubmission |
| Competing Supplement | Revision |

- R&R Type of Application also include “Continuation”.  This is equivalent to our Progress Report or T-5.  NIH will not use the R&R for progress reports.

## New Terminology

| NIH Term | (R&R) Term |
| --- | --- |
| PA and/or RFA | Funding Opportunity Announcement (FOA)—general term for all  PAs and RFAs |
| PI | PD/PI:  Combined term |
| Authorized Organizational Official (AOO) or Signing Official (SO) | Authorized Organizational Representative (AOR) |
| Other Support | Current & Pending Support |

## New Terminology

| NIH Term | (R&R) Term |
| --- | --- |
| Literature Cited (Part G. of 398 Research Plan)  | “Bibliography & References Cited” in R&R Other Project Information Component |
| Consortium Budget  | Subaward Budget |

## Electronic Submission Information:

- _[http://](http://era.nih.gov/ElectronicReceipt/)__[era.nih.gov/ElectronicReceipt](http://era.nih.gov/ElectronicReceipt/)__[/](http://era.nih.gov/ElectronicReceipt/)_

## Application Guide(s), Sample Application Packages, Additional Format Pages found at: 

- _[http://grants.nih.gov/grants/funding/424/index.htm](http://grants.nih.gov/grants/funding/424/index.htm)_

## Finding Help: Grants.gov Registration & Submission

- If help is needed with the Grants.gov registration process or with the technical aspects of submitting through the Grants.gov system:
- Check the resources available on the Grants.gov website first (_[http://](http://grants.gov/)__[grants.gov](http://grants.gov/)__[/](http://grants.gov/)_ )
- Grants.gov help is also provided by the following office:
- Grants.gov customer support
- Contact Center Phone: 1-800-518-472
- Business Hours M-F 7 a.m.-9 p.m. Eastern Standard Time
- Email _[support@grants.gov](mailto:support@grants.gov)_

## Finding Help: eRA Commons Registration & Validations Processes 

- If help is needed with the eRA Commons registration process for the applicant organization and principal investigators, or with the application validation process in the eRA Commons after submission through Grants.gov, contact:
- eRA Commons help deskPhone: 301-402-7469/866-504-9552 (Toll Free) 301-451-5939 (TTY) Business hours M-F 7am-8pm Eastern Standard TimeEmail _[commons@od.nih.gov](mailto:commons@od.nih.gov)_
- Also visit:
- eRA Commons website: _[https://](https://commons.era.nih.gov/commons/index.jsp)__[commons.era.nih.gov/commons/index.jsp](https://commons.era.nih.gov/commons/index.jsp)_
- eRA website: _[http://era.nih.gov](http://era.nih.gov/)_

## Finding Help: Application Preparation

- Review application instruction guide(s)
- Contact Grants Info:
- Grants Info
- Phone: 301-435-0714
- 301-451-0088 (TTY)
- Email _[GrantsInfo@nih.gov](mailto:grantsinfo@nih.gov)_
- All these help resources are found at: _[http://era.nih.gov/](http://era.nih.gov/ElectronicReceipt/support.htm)__[ElectronicReceipt/support.htm](http://era.nih.gov/ElectronicReceipt/support.htm)_

## Collecting User Feedback

- NIH has established an e-mail address to collect comments and/or suggestions from users:
- _[NIHElectronicSubmiss@mail.nih.gov](mailto:NIHElectronicSubmiss@mail.nih.gov)_.
- Share your experiences—successes and challenges
- Share specific suggestions for improvement
- What resources are most useful (*Targeted e-mails, FAQs, Tips & Tools, Commons Alerts, Training tools*)

## Next Steps

- Review E-Application website: _[http://era.nih.gov/](http://era.nih.gov/ElectronicReceipt/)__[ElectronicReceipt](http://era.nih.gov/ElectronicReceipt/)__[/](http://era.nih.gov/ElectronicReceipt/)_
- Familiarize yourself with the forms and application guide(s)
- Application guides and sample versions of application packages are available at:  _[http://grants1.nih.gov/grants/funding/424/index.htm](http://grants1.nih.gov/grants/funding/424/index.htm)_
- Must have PureEdge Viewer installed in order to manipulate the sample application packages.  (***Check with your IT folks for permission and assistance in downloading this software)***
- Review available training resources:  brochures, video library, video webcasts:   _[http://era.nih.gov/](http://era.nih.gov/ElectronicReceipt/training.htm)__[ElectronicReceipt/training.htm](http://era.nih.gov/ElectronicReceipt/training.htm)_
- Share experiences:  1) Network at mtgs; 2) Listservs
- Determine implementation plans for *your* Institution
- Spread the word—The SF424 (R&R) & electronic submission through Grants.gov are here!