# Presentation: 719072

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

**NIH Office of Extramural Research**
**October 2008**

**Notes:**
Changes to electronic applications are on the way.
Learn how this affects you today!

## What is the SF424 (R&R)?

- Stands for Standard Form 424 – _**R**_esearch and _**R**_elated.
- Is actually a combination of separate forms focusing on the many aspects of a proposed grant.
- Is used government-wide to apply for all Research and Research-related grants.
- Used by 15 different Federal agencies
- Based on needs of all agencies, and not tailored to specific agencies, funding opportunities, or grant programs
- Allows use of agency-specific forms and special instructions where appropriate

## Features of the SF424 (R&R)

- A complete application to NIH will include a combination of (R&R) components & PHS 398 components.
- The applicant **must** complete the application using the package attached to that particular Funding Opportunity Announcement  (*Information is drawn from the specific FOA and auto-completed for use in the forms).*
- Applicants should *not* use any forms or sample forms from other announcements.
- Allows applicants to complete data entry in all necessary components and upload appropriate attachments.

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

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

**Notes:**
The Project/Performance Site Location form is used by all form sets, not just Research & Related

## 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, these agency-specific components (titled PHS 398) were also developed:
- PHS 398 Cover Letter File
- PHS 398 Cover Page Supplement *(supplements the R&R Cover)*
- PHS 398 Modular Budget
- PHS 398 Research Plan
- PHS 398 Checklist
- New PHS forms for Fellowship (F), Career Award (K) and Training (T)

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

- NIH has developed two, specific SF424 (R&R) Application Guides: 1) General Instructions; 2) General + SBIR/STTR
- Includes instructions that are imbedded in the actual forms as well as agency-specific instructions
- Agency-specific instructions denoted with the HHS Logo
- Application Guides are split into three parts:
- 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

## Accessing Application Forms

***Find*** a grant opportunity in Grants.gov or the NIH Guide for Grants and Contracts.
- Click on “Apply for Grant Electronically” button in the Funding Opportunity Announcement (FOA).
- FOA will link to Grants.gov where applications and instructions are available for download.
- In Grants.gov, use the FOA number for searching and confirming you are responding to the correct announcement.

## Header Information 

- Header Information
- Pre-filled from announcement

## Navigating Application Forms

- The **Grant Application Package Screen **provides access to all appropriate forms, both components that are required (mandatory) and those that are optional.
- Some forms that are listed as optional for Grants.gov are actually required by NIH.  For example, both modular budget forms and R&R budget forms are listed as optional, though you must submit at least one (but never both).
- Click on form and move it to submission box, then open to fill in application information.
**Adobe Only – **Grants.gov mandatory fields are outlined in red and shaded in yellow.
- Not all fields required by NIH are marked mandatory on the forms.

## SF424 (R&R) 

**Cover Component**
**Page 1**

## Notes on SF424 (R&R) Cover Component – Page 1

- Always start with the Cover Component.  Information entered here pre-populates other components.
- General information about the applicant organization, contact information for the PD/PI and Authorized Organizational Representative.
**Item 1, Type of Submission**
- Pre-application—instructed not to use unless specifically noted in FOA (used by X02 grant mechanism).
- Changed/Corrected Application— Only use when correcting an application that failed system validations.  This is NOT a resubmission.
**Item 5, Organizational DUNS** must match DUNS in eRA Commons profile and Grants.gov registration.
**Item 6**, Include **email** of person to be contacted; NIH sends notifications to this address in addition to email addresses provided for PD/PI and AOR.

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

**Item 8, Type of** **Application- **
- New is an application submitted for the first time
- Resubmission is 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
**Item 14, Congressional District** will be moving to the Project/Performance Site Locations form in near future.

**Notes:**
Item 14 Congressional District, currently on the SF424 RR cover, will move to the Project/Performance Site location, when the new Adobe forms debut in December 2008.

## SF424 (R&R) Cover Component - Page 2

## Project/Performance Site Locations

- Collects data for up to eight locations
- More than 8 locations requires a text attachment
- Format for the attachment available at http://grants.nih.gov/grants/funding/424/index.htm

## Other Project Information

**Other Project Information**

## Other Project Information

**Items 1 and 2, Human Subject Involvement and Vertebrate Animal Use – **Approval dates still provided as just-in-time information.
- Check Yes to “Is the IRB Review Pending” and “Is the IACUC Review Pending” even if process has not begun at time of submission.
**Item 7, Project Narrative** – Use for the public health relevance section.
**Item 11, Other Attachments** – Only complete this item when requested in the FOA.

## Senior/Key Person Profile - Expanded

**Senior/Key Person Profile - Expanded**

## Senior/Key Person Profile

- Captures personal profile information on PD/PI, key personnel, and other significant contributors.
- eRA Commons “Credential” mandatory for all PD/PIs
- Organization Name is also required by NIH.
- Attach a Biographical sketch for each person.  Format and samples are available from the SF424 (R&R) Forms Page.
- Do not attach “Current & Pending Support” unless requested in FOA.  This will be requested later during the just-in-time process.
- Form captures PD/PI plus 39 others.
- Form can also be used for “Other Significant Contributors”.
- Two new designations – Post-Doc Scholar and Co-Investigator – will be added soon to ‘Project Role.’
- The degree information will be pulled off the PHS 398 Cover Page Supplement in the near future.

**R&R Forms Page available at: grants.nih.gov/grants/funding/424/index.htm**

## Research and Related Budget - General Notes

- R&R Budget Form is one of two “optional” forms for submitting budget information.
- Modular budgets do not use these forms, but instead use a PHS 398 form.
- See FOA and SF424 (R&R) Instruction Guide for information on when to use each type of budget form.
- Applicant prepares a detailed budget for *every* budget period.
- A detailed Cumulative budget will be system-generated based on the budget period data.

## R&R Budget

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

## R&R Budget Sections A & B

- Personnel separated into 2 sections:
- A.  Senior/Key Person
- Allows 8 as separate named individuals
- Provide info on additional Senior/Key persons in a text attachment
- Provide time in “person-months” units, not percent effort
- PD/PI field must be filled-in
- B.  Other Personnel
- Postdocs, Grad Students, Undergrads:  Only the number of personnel is required (not specific names or responsibilities)
- Provide more detail in Budget Justification
- “Base Salary” can be left blank when applying but NIH will require the information before the grant is awarded

**Person-month FAQs: grants.nih.gov/grants/policy/person_months_faqs.htm**

## R&R Budget Sections C - E

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

## R&R Budget Sections C - E

**Item C, Equipment** allows itemization of up to 10 pieces of equipment.  If more, include total dollars in line 11 and provide details in the attachment.
**Item D, Travel** separates Domestic and Foreign travel, but NIH continues to award as a single category.
**Item E, Participant/Trainee Support Costs** not used unless requested in FOA.

## R&R Budget

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

- Include tuition remission in **Item F, Other Direct Costs.**
**Item F(5), Consortium Costs** is not auto-populated.
**Next Period Button** at top of page not available until all required data fields in this component are completed, including the budget justification.

## Slide 25

## R&R Subaward Budget Attachment Form

- Used for detailed budget from all consortium grantees.
- 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.
- Consortium grantee(s) must have a version of Adobe Reader that is compatible with Grants.gov’s forms.
- Allows up to 10 separate budget attachments.
- Provide one budget for each consortium grantee
- If more than 10 consortium partners, include details for 11 and above as PDF documents in budget justification.

## SBIR/STTR Information

**Page 1**

## SBIR/STTR Information (Pages 1 and 2)

**Item 1, Eligibility **– Applicants must meet SBIR/STTR eligibility requirements at time of award, not time of application.
**Item 6, Disclosure Permission Statement** – Allows NIH to share contact information and project title to outside partners for possible collaborations or investments.
**Item 7, Commercialization Plan **– Include as a PDF attachment.

## SBIR/STTR Information(Page 2)

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

- Form pages used in addition to standard SF424, and included in the NIH form set:
- PHS 398 Cover Letter File
- PHS 398 Cover Page Supplement *(supplements the R&R Cover)*
- PHS 398 Modular Budget
- PHS 398 Research Plan
- PHS 398 Checklist
- New PHS forms for Fellowship (F), Career Award (K) and Training (T)
- Allows NIH to collect information not provided by other research agencies.

## PHS 398 Cover Letter

- A suggested format for cover letters is described in SF424 (R&R) Application Guides.

## PHS 398 

**Cover Page Supplement **
**Page 1**

## PHS 398

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

## PHS 398 Cover Page Supplement Pages 1 and 2

- Companion forms to the (R&R) Cover Component providing NIH with additional needed information.
- For the PD/PI, includes **New Investigator** code & **Degree** fields.
- Includes **Clinical Trial** and **Agency-Defined Phase III Clinical Trial** indicators.
- For the Business Official Contact, includes complete contact information (*title & mailing address missing from section 5 of the R&R Cover).*
- Page 2 includes **Human Embryonic Stem Cells** item.

## PHS 398 Modular Budget

**PHS 398 Modular Budget**

## PHS 398 Modular Budget

- Alternative to the R&R Budget form that doesn’t require detailed categorical information.
- Available to certain applicants requesting $250,000 or less in Direct Costs per year.
- Applicants must request total direct costs in “modules” of $25,000.
- Direct costs are separated from consortium F&A costs since these are not included in the $250K limit.
- Cumulative Budget is system-generated.
- Form requires Budget Justification PDF text attachments for Personnel, Consortium and Other.

## PHS 398 Research Plan

**PHS 398 Research Plan**

## PHS 398 Research Plan

- Separate PDF attachments for each section.
- Same formatting requirements in the PHS 398 continue here—margins, page limits, etc.
- Appendix Material
- Allows up to 10 separate attachments
- Stored separately in the eRA grant folder, not as a part of the main application grant image
- Accessible to appropriate NIH staff and peer reviewers

## PHS 398 Research Plan:Helpful Hints

- Create as a single document using any word processing software to track page limits.  Separate only at the end before uploading.
**Do not** include headers or footers.
**Do** include a section heading as part of the text; i.e., Specific Aims, Background & Significance.

## PDF Attachment Hints

- Do not scan paper documents.  Instead, produce documents with word-processing software and then convert electronically to PDF.
- Use meaningful titles for file names.
- Only use standard characters in file names: A-z, 0-9, Hyphen (-), Underscore ( _ ).
- Disable write-protection features.
- A zero-byte attachment is an invalid PDF.

**More at: era.nih.gov/electronicreceipt/pdf_guidelines.htm**

## PHS398

- Captures data on **Inventions and Patents**

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

## PHS398

**Checklist**
**Page 2**

- Captures additional information on sources of** Program Income.**
- Allows PDF text upload if unable to certify compliance.

## Slide 43

## Application Submission

- Save the final application document and click “Check Package for Errors” on Grant Application Package Screen. This checks for Grants.gov errors, not NIH-generated errors.
- Once all documents are properly completed and saved the “Save and Submit ” button becomes active.
- Once submitted, verification and confirmation screens will appear, and applicants will receive a Grants.gov Tracking Number.

## Application Submission

- Check header information one last time to confirm you are submitting to correct FOA and that it has not yet closed.

## After Submission to Grants.gov

- After submission to Grants.gov, the **eRA system** performs agency validations.
- Any errors must be fixed and the application resubmitted before it can be accepted for review
- Warnings may not require fixing, but highlight potential problems/issues for applicants to consider
- If no eRA system errors identified, the eRA system will:
- Assemble the grant image
- Generate a Table of Contents
- Include headers (PI name) & footers (page numbers) on all pages
- Applicants have a two business-day viewing window after successful receipt by NIH to ensure the application was submitted correctly.

## 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****	****	****	****	**_**	**_

## Handy Tools and Final Thoughts

## http://era.nih.gov/ElectronicReceipt/ 

- http://era.nih.gov/ElectronicReceipt/

## http://grants.nih.gov/grants/funding/424/index.htm 

- http://grants.nih.gov/grants/funding/424/index.htm

## Training Tools:

- Registration in the eRA Commons Demo _[http://era.nih.gov/virtualschool/external/c101_GranteeRegistrationProcess.htm](http://era.nih.gov/virtualschool/external/c101_GranteeRegistrationProcess.htm)_
- Grants.gov’s How to Complete An Application Package Demo _[http://](http://www.grants.gov/CompleteApplication#demo)__[www.grants.gov/CompleteApplication#demo](http://www.grants.gov/CompleteApplication#demo)_

## Other Tools

- SF424 (R&R) application guides, additional format pages and related resources http://grants.nih.gov/grants/funding/424/index.htm
- Frequently Asked Questions http://era.nih.gov/ElectronicReceipt/faq.htm
- Frequently Asked Questions re: Person months http://grants.nih.gov/grants/policy/policy.htm#resources
- Avoiding Common Errors http://era.nih.gov/ElectronicReceipt/avoiding_errors.htm
- Resources for NIH Adobe Transition http://era.nih.gov/ElectronicReceipt/adobe_transition.htm

## Finding Help: 

- Review application instruction guide(s)
- Contact Grants Info:
- Grants Info
- Phone: 301-435-0714
- 301-451-0088 (TTY)
- Email GrantsInfo@nih.gov
- All other tools and resources are found at:
- http://era.nih.gov/ElectronicReceipt/index.htm

## Finding Help: Commons Registration & Validations

- If help is needed with the eRA Commons registration process for the applicant organization or PDs/PIs, or with the application validation process in the eRA Commons after submission through Grants.gov, contact:
- 	**eRA Commons Help Desk** Web: http://ithelpdesk.nih.gov/eRA/
- 	Toll-free: 1-866-504-9552Phone: 301-402-7469TTY: 301-451-5939Hours: Mon-Fri, 7a.m. to 8 p.m. Eastern Time
- Also visit:
- eRA Commons website: https://commons.era.nih.gov/commons/index.jsp

## Collecting User Feedback

- NIH has established an e-mail address to collect comments and/or suggestions from users:
- NIHElectronicSubmiss@mail.nih.gov.
- Share your experiences—successes and challenges
- Share specific suggestions for improvement
- What resources are most useful (*Targeted e-mails, FAQs, Adobe Transition Resources, Avoiding Common Errors, Training tools*)

## Questions?