1. A Walk Through The SF424 (R&R)
Presented by
Scott Cooper & Emily Linde
Office of Policy for Extramural Research Administration
Stands for Standard Form 424 – Research and Related
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

2. SF424 (R&R)
Complete application includes combination of (R&R) components & PHS 398 components
Must complete SF 424 (R&R) using package attached Funding Opportunity Announcement (Information is drawn from specific FOA and auto-completed for use in the forms)
Complete data entry in all necessary components and upload appropriate attachments
Applicants should not use any forms or sample forms from other announcements

3. SF424 (R&R) (cont.)
SF424 (R&R) Components used for NIH grant applications 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 - Expanded
Research & Related Budget
R&R Subaward Budget Attachment Form
SBIR/STTR Information
Research & Related Personal Data (NIH does not use – form gives us authority to collect this information via eRA Commons)

4. SF424 (R&R) (cont.) NIH requires agency-specific components:
PHS Cover Letter
PHS 398 Cover Page Supplement (supplements R&R Cover)
PHS 398 Modular Budget
PHS 398 Research Plan
PHS 398 Checklist
PHS 398 Career Development Award Supplemental Form
PHS Fellowship Supplemental Form
Letters of Reference
PHS 398 Training Budget Forms
PHS 398 Research Training Program Plan
NOTE that the letters of reference are not a grants.gov form and are submitted through the NIH Commons and not Grants.gov

5. SF424 (R&R) Application Guides
NIH has developed three SF424 (R&R) Application Guides:
1) General Instructions
2) SBIR/STTR
3) Fellowships
Agency-specific instructions denoted with HHS Logo
Application Guides are divided 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 And Other Information

6. Accessing Application Forms
Find a grant opportunity in Grants.gov or NIH Guide to 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 to search and confirm you are responding to the correct announcement

7. Header Information
Prefilled from Announcement

8. Navigating Application Forms
Grant Application Package includes all appropriate forms, components that are required (mandatory) and those that are optional.
Some forms listed as optional are actually mandatory. Click on form and move it to submission box, then open to complete form.
Fields highlighted in red and shaded in yellow are mandatory!
NOTE: NIH has additional fields that are required but not mark as mandatory: e.g. –
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).

9. SF424 (R&R)
Cover Component
Page 1

10. Notes on SF424 (R&R) Cover Component – Page 1
Start with Cover Component
Item 1, Type of Submission
Pre-application — do not use unless specifically noted in FOA.
Changed/Corrected Application — use only when correcting an application that failed NIH system validations. This is NOT a resubmission.
Item 4b, Agency Routing Identifier do not use unless specifically noted in FOA
Item 5, Organizational DUNS must match DUNS in eRA Commons profile.
Information entered here pre-populates other components
What types of information are on the cover component:
General information about the applicant organization, contact information for the PD/PI and Authorized Organizational Representative

11. 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 to address reviewer feedback
Renewal is used when competing for additional years of funding to continue project.
Continuation NIH does not use SF424 R&R continuation applications.
Revision request for additional funds to expand scope
Item 13, Congressional District for applicant organization only
Item 13: Note that the Congressional District information for performance sites is now on the Project/Performance Site Locations Component form.

12. SF424 (R&R)
Cover Component
Page 2
See Application Guide Section III

13. Project/Performance Site Locations
More than 30 locations requires an attachment
Available at

14. Other Project Information

15. Other Project Information
Items 1 and 2, Human Subject Involvement and Vertebrate Animal Use – Approval dates provided as JIT
Check yes to “Is the IRB Review Pending” and “Is the IACUC Review Pending” even if process has not begun at time of submission.
If IRB review is pending, Human Subject Assurance Number will be collected with JIT.
Item 8, Project Narrative – Use for the public health relevance section
Item 12, Other Attachments – complete only when requested in FOA
Talk to Sheri about difference in collection of FWA and animal assurance numbers is pending

16. Senior/Key Person Profile - Expanded
More than Senior/Key Persons requires an attachment
Credential and Organization name are REQUIRED, though not highlighted

17. Senior/Key Person Profile
Captures personal profile information on PD/PI, key personnel, and other significant contributors.
eRA Commons “Credential” mandatory for all individuals with PD/PI role
For multiple PD/PI applications, individual designated as contact PD/PI must be affiliated with applicant organization in the eRA Commons
Attach a Biographical sketch for all key personnel.
Format and samples are available from the SF424 (R&R) Forms Page.
Do not attach “Current & Pending Support” unless requested in FOA.
Include organization for all senior/key personnel
This will be requested later during the just-in-time process.
R&R Forms Page available at: grants.nih.gov/grants/funding/424/index.htm

18. Research and Related Budget
R&R Budget Form is one of two “optional” budget components. The other is the PHS 398 Modular Budget Form.
See FOA and SF424 (R&R) Instruction Guide for which type of budget component to use
Complete components only for your own organization.
Subawardees will complete components for their organization and provide to applicant organization.

19. Research and Related Budget
Applicant prepares a detailed budget for every budget period
A detailed cumulative budget will be system-generated based on budget period data.

20. R&R Budget Sections A & B

21. R&R Budget Sections A & B
Personnel separated into 2 sections:
A. Senior/Key Person
Allows 8 named individuals
Information on additional Senior/Key persons provided in .pdf attachment
Provide time in “person-month” units, not percent effort
PD/PI field must be completed
B. Other Personnel
Postdocs, Grad Students, Undergrads: Only the number of personnel is required (not specific names or responsibilities).
More detail provided in Budget Justification
NIH recommends providing actual “Base Salary”
Base salary – if 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

22. Additional Notes on Personnel
R&R Budget Form
Senior/Key Personnel
Include only personnel employed by (e.g., receiving salary from) your organization.
Include all personnel considered senior or key, regardless of employer.
Consultants should be included in Section F Line 3 or Section A (if they are both senior/key and employed by the application organization).
Include if considered senior or key, regardless of employer.
Do not include other significant contributors in personnel section of R&R Budget.
Effort commitments not relevant to this section.

23. R&R Budget
Sections C - E

24. 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.

25. 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 not available until all required data fields are completed, including the budget justification attachment.
Include tuition remission in Item F, Other Direct Costs – you must write these costs in (item 8-10)

27. R&R Subaward Budget Attachment Form
Used for detailed budget from consortia
Subawardees must use correct Adobe Reader version
Applicant sends R&R Subaward budget component to Subawardee(s); it is completed and returned; applicant attaches it in this component
Allows up to 10 separate subaward budget attachments
Provide one budget for each consortium grantee
If more than 10 subawardees, include details for additional subawardees in budget justification (Section K)

28. SBIR/STTR
Information
Page 1

29. SBIR/STTR Information
Page 2

30. SBIR/STTR Information (Pages 1 and 2)
Item 1a, 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 parties for possible collaborations or investments.
Item 7, Commercialization Plan – Include for Phase II or Fasttrack applications
Item 6 disclosure is not required, but you must respond to the question
Item 7 required only if application is for a phase ii or fasttrack application

31. Agency-specific Components (a.k.a. PHS 398 Components)
Form pages required in addition to standard SF 424 R&R, and included in the NIH form set:
PHS Cover Letter File
PSH 398 Cover Page Supplement (supplements the R&R Cover)
PHS 398 Modular Budget
PHS 398 Research Plan
PHS 398 Checklist
PHS 398 Career Development Award Supplemental Form
PHS Fellowship Supplemental Form
PHS 398 Training Forms
Allows NIH to collect information not provided to other research agencies.
All of the forms that I am going to discussion are not used in the standard SF424 – in other words they are agency specific. We use them to collect information necessary to make an award and to meet our own reporting requirements.
Cover letter is optional, but encouraged, we’ll go over why in just a minute
Cover page supplement is exactly what it sounds like, we use this to collect information that we need but is not collected on the SF424 R&R cover component
Modular budgets, we’ll go into these in more detail later in the presentation – must be used when you are eligible and replaces the detailed budget when you use them

32. PHS Cover Letter
Encourage you to use
Why you might:
To request specific study section or assignment to specific IC, list of individuals who should not review the application and why
When you have to:
Submitting unsolicited application in excess of $500K – received approval to do so
Corrections after the deadline – explaining reason for correction
Submitting late for natural disaster – specific information about timing and cause of delay
Fellowships – consult guide for what must be included in this letter (referees – name, dept, and inst), app title, foa,
A suggested format for cover letters is described in all SF424 (R&R) Application Guides

33. PHS 398 Cover Page Supplement Page 1
Items 1 should prepopulate – this is why you are always going to start with the SF 424 R&R
Item 2 captures clinical trial information not collected with the rest of the human subjects information in the SF 424 R&R components
Item 3. captures all of the contact information we need to communicate with you effectively. Some of this is collected on the SF 424 R&R, but not all of it.

34. PHS 398 Cover Page Supplement Page 2
Lastly, item 4 is for human embryonic stem cells
You’ll indicated yes or no to hESC involvement, if yes:
Use the boxes down the left hand side are where you will enter the number of the cell lines approved on the Registry. If none are appropriate, use the checkbox to indicate that you can’t identify one at this time, but that one from the registry will be used.
I just want to step back a little here, because it has been less than a year since we issued guidance on the new hesc policy and just over 6 months since the registry posted the first approved lines. There have been a fair number of Guide Notices released on these and if you have any applications with hesc research I would encourage you to review those. Lastly, some of the approved lines have use restrictions, so if you select those lines you must be able to comply with those use restrictions

35. PHS 398 Cover Page Supplement Pages 1 and 2
Companion forms to the (R&R) Cover Component providing NIH with additional needed information
Item 2. Human Subjects - includes Clinical Trial and Agency-Defined Phase III Clinical Trial indicators
Item 3. Applicant Organization Contact, includes complete contact information (title & mailing address missing from section 5 of the R&R Cover)
Item 4. Human Embryonic Stem Cells
To recap collecting information not collected on the SF 424 R&R :
Clinical trial, stem cell, and contact info

36. PHS 398 Modular Budget
I know it might look funny to have a total that is dc less consortium f&a Plus consortium f&a, but there is a method to the madness here. consortium f&a does not count toward the$250 K modular cap. This confuses some people. When I was a specialist I used to get this question all the time: so that means that consortium f&a doesn’t count as dc for our inst. NO. It is still counted as dc for our inst it is just not counted toward the modular cap. So the important box here is the yellow box. As long as that is less than $250, AND you are eligible, you should submit a modular.
Why wouldn’t you be eligible? If you’re a foreign institution (all foreign inst must submit detailed budgets). You’re applying for a small business award. if the foa specifically requests detailed budgets.
All requests must be in modules of 25,000. the form will not let you put anything else in there. So the request will be 175, 200, 225, 250…
Can request up to five years depending on type of application and FOA instructions.
How do you prepare the budget? Just like you would any other. You’re institution may even require you to submit a detailed budget to them. You prepare the budget, add it up and it comes to 192,000. you’ll round up to 200.
You need a piece of equipment in the first year, or the science truly demands different costs in one year – JUSTIFY the fluctuation.
Why you might have multiple rates: your predetermined rates will change during the proposed budget period. offsite fac

37. PHS 398 Modular Budget
Alternative to the R&R Budget form that doesn’t require detailed categorical information.
Available to certain applicants requesting Direct Costs of $250,000 or less per year.
Consortium F&A costs are not included in the $250,000 limit.
Applicants must request total direct costs in “modules” of $25,000.
Cumulative Budget is system-generated
Budget Justifications PDF text attachments
for Personnel, Consortium and Other
recap

38. PHS 398 Research Plan
Items 1 should pre-populate – this is why you are always going to start with the SF 424 R&R
Each going to be separate pdf attachments

39. PHS 398 Research Plan
Same formatting requirements in the PHS 398 apply here—margins, page limits, etc.
Separate PDF attachments for each section Appendix Material
Allows up to 10 separate attachments
Review FOA for what can be submitted in appendix. May have specific limitations.
Work as a single documents with word processing software and then pull apart an name carefully. You’ll want to name it some thing so you can be sure that you are attaching the right document (of course you’ll check everything before submitting) and you want to be able to find them. We do see the names on these attachments.
Cannot use to circumvent page limits
If information needs to be in the application you should include it in the application (eg. Budget justification). Reviewers see this material, but not everyone else does.
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

40. PHS398 Checklist Page 1 Captures data on Inventions and Patents
Items 1 should pre-populate – this is why you are always going to start with the SF 424 R&R
Item 2. use as appropriate, you may be requesting to name a new pd/pi because the former pd/pi is retiring.
Item 3. if you check yes, you’ll need to answer if it has been previously reported. You are also still responsible for reporting the invention through iEdison.

41. PHS398
Checklist
Page 2
Captures additional information on sources of Program Income

42. Environ/Inst Commitment Research Plan Human Subjects
Career
Development
Award
Attachments
Candidate Info
Statements of Support
Environ/Inst Commitment
Research Plan
Human Subjects
Items 1 should pre-populate – this is why you are always going to start with the SF 424 R&R
Similar to the previous form except has information on candidate, statements of support, and institutional commitment
Formatting rules and page limits also apply to ks – 12 pages but you’ll always want to check the foa for any special instructions or deviations from page limits.

43. Career Development Award Attachments - Other Research Plan Sections
- Appendix
Just want to point out here that citizenship requirements in effect for most Ks at determined at the time of award, not the time of application.
Pls. check only one box.

45. Fellowship Supplemental Form (cont…)
For items 17 and 18 there is a one page limit

46. Talk about stem cells

47. For the appendix – cannot be used to circumvent the page limitations
Letters of reference are submitted separately through the Commons on the fellowship reference form. They are attached to the application at NIH once we have received the application and all three reference letters.

48. Fellowship Supplemental Form
Item B. - Research Training Plan includes: specific aims and a research strategy
Item B. 1 - Introduction to application required for resubmissions – only
Item B. 17 – Respective Contributions: describe collaboration between fellow and sponsor.
Item C Applicants must meet citizenship requirements at time of award, not time of application.
Review FOA for applicable citizenship requirements, which may differ for a few F mechanisms

49. For the appendix – cannot be used to circumvent the page limitations
Letters of reference are submitted separately through the Commons on the fellowship reference form. They are attached to the application at NIH once we have received the application and all three reference letters.
Indirect on NRSA training grants is 8% excluding tuition/fees, equipment, and subawards

50. For the appendix – cannot be used to circumvent the page limitations
Letters of reference are submitted separately through the Commons on the fellowship reference form. They are attached to the application at NIH once we have received the application and all three reference letters.

51. PHS 398 Training Budget Mandatory for NRSA grant programs.
3 Types of Training Budgets
Appropriate one will be defined for you by FOA
Consult FOA for non-NRSA programs to determine, which budget form pages to use.
Training budget forms are designed to capture the information specific to training grants ie the number and types and stipend levels for trainees, training related expenses.
PHS 398 Training Subaward budgets are rarely used – but are used when a portion of the training is conducted at a site other than the grantee institution via a consortium agreement.

52. PHS 398 Research Training Program Plan
For the appendix – cannot be used to circumvent the page limitations
Letters of reference are submitted separately through the Commons on the fellowship reference form. They are attached to the application at NIH once we have received the application and all three reference letters.

53. PHS 398 Training Research Program Plan
Item – combined page limit is 25 pages
Item 2.5 – Plan for Instruction in Responsible Conduct of Research is required for all training grant activity codes (except T36).
Item 2.13 Data Tables – the attachment for the user defined bookmarks will be pulled into the NIH application image.
Training forms are designed to capture the information specific to training grants ie the number and types and stipend levels for trainings, training related expenses.

54. PHS 398 Research Plan: Helpful Hints
Do not include headers or footers
Do include a section heading as part of the text; e.g., Use heading of Significance, Innovation, and Approach in Research Strategy

55. PDF Attachment Hints Do not scan paper documents.
Use meaningful titles for file names
Only use standard characters in file names: A-Z, 0-9, Underscore ( _ ).
Disable write-protection features.
A zero-byte attachment is an invalid PDF.
Scanned documents often are not legible.
Yes, we see file names for attachments
(letters of support are ok – they usually scan alright.
More at:

57. Application Submission
Save final application document and click “Check Package for Errors” on Grant Application Package Screen.
Once all documents are properly completed “Save & Submit” button becomes active.
After clicking “Save & Submit,” Application Submission Verification and Signature screen will appear.
Confirm you are responding to correct FOA.
After clicking “Sign and Submit Application” applicants will receive a Grants.gov Tracking Number.
ONLY A SUBSET OF GRANTS.GOV ERRORS ARE CHECKED AT THIS POINT, SO YOU DEFINITELY NEED TO LOGON AND CHECK YOU APPLICATION IN THE COMMONS.

58. Click Sign and Submit Application.

59. Print/Save your Confirmation screen info
Grants.gov Tracking #

60. Handy Tools and Final Thoughts

61. REPLACE

63. Tools
Training
Other
Frequently Asked Questions
Avoiding Common Errors
Communications Resources (brochures, presentations, drop-in newsletter articles)
eRA Commons Demo Grants.gov’s How to Complete An Application Package Demo

64. Enter your own help ticket!
Finding Help:
Review application instruction guide(s)
Grants Info
Phone:
(TTY)
eRA Commons Help Desk
Phone: /
(TTY)
Grants info
Finding grant-related resources and referrals
Identifying research and research training programs
Locating information and guidelines on the Internet
Answering questions about the SF424 (R&R) application forms
Answering general questions about electronic submission
Answering questions about research grant applications, fellowship applications and the application review and award process
eRA Commons registration process or with the application validation process in the eRA Commons after submission through Grants.gov
Grants.gov
Grants.gov Registration
Downloading or navigating forms
Technical aspects of submitting to the Grants.gov system
Enter your own help ticket!

65. Contact Information
Scott Cooper –
Emily Linde
Grant Policy Inbox –
THANK YOU!

66. Questions?