Proposal submission to NIH via Grants

1. Proposal submission to NIH via Grants.gov Completing the Grant Application Package Forms, fields and attachments Updated June 2007

2. Completing the Grant Application Package

3. Features of the SF424 (R&R) • SF424 (R&R) documents include standard forms used by all Federal agencies: • Application Package Header • SF424 (R&R)— Cover Page • Research & Related Project/Performance Site Location(s) • Research & Related Other Project Information • Research & Related Senior/Key Person Profile • Research & Related Budget • R&R Subaward Budget Attachment Form

4. Features of the SF424 (R&R) • Some agencies have developed forms to capture data particular to that agency’s grants • NIH’s agency-specific documents include: • PHS 398 Cover Letter File • PHS 398 Cover Page Supplement • PHS 398 Modular Budget • PHS 398 Research Plan • PHS 398 Checklist

5. Features of the SF424 (R&R) • Read and follow agency instructions to determine mandatory fields and other requirements • All fields in YELLOW are mandatory • An asterisk* also indicates a mandatory field • Check instructions for fields that are NOT YELLOW and not asterisked - some fields are mandatory for certain agencies or applications • “Optional Documents” may not be optional for a particular Funding Opportunity Announcement - CHECK INSTRUCTIONS • “Check Package for Errors” button only checks Grants.gov validations - it may say “no errors” even if an NIH-required attachment is missing • PDF files are recommended for attachments even if the agency does not require PDF files

6. Attachments • Most of the application text - research plan, biosketches, resources, etc. - must be uploaded as attachments to the Grant Application Package. NIH requires pdf attachments. • Create each attachment in Word (or similar applications). Once it is final, convert the document to pdf format • The only documents that should be scanned rather than converted are letters of support and, when necessary, appendix documents • Don’t add any headers or footers • NIH provides format for some attachments: http://grants.nih.gov/grants/funding/424/index.htm

7. Attachment tips • Use short file names for your pdf attachments that are relevant to the application section, eg, ProjectSummary.pdf”. • Once you have added an attachment, your pdf file name will appear in the field and the “Delete Attachment” and “View Attachment” buttons will be activated. You should then be able to open and view your pdf file, or delete it and upload a correct or updated pdf file. • Avoid special characters in the file name - see guidelines at: http://era.nih.gov/ElectronicReceipt/pdf_guidelines.htm# • Be sure to “save” the Grant Application Package as you add attachments.

8. SF424 (R&R) Application Package Header • Header page with pre-filled data about the Funding Opportunity (FOA) is attached to every posted application package • Helps you verify that this is the correct opportunity • DO NOT change the pre-filled Header data • Mandatory and optional documents for the particular FOA are listed • Complete the yellow field, “Application Filing Name” with information about this application, including the PI last name (e.g., Smith R21) • Move completed forms from the left box to the right box -- highlight the form name and use the button “Move form to submission list” (circled)

9. Header Information Pre-filled from announcement

10. SF424 (R&R)—Cover Page • Similar to the PHS398 Face Page • Captures general information about the applicant organization, contact information for the PD/PI and Authorized Organizational Representative (ORD) • Provides application-specific information (application type, project title etc.) • Complete this document FIRST as these data populate other documents

11. SF424 (R&R) Cover Page Page 1 (items 1-15) Required for Resubmissions & Renewals (see slide 44) Double-check your project dates - be sure they are correct before you SAVE

12. SF424 (R&R)— Cover Page • Item 1, Type of Submission • Pre-application—use only if specifically noted in FO • Changed/Corrected application—used only when correcting an application that failed NIH system validations. This does NOT indicate a Resubmission application. • Item 4, Federal Identifier • Blank for New applications • For a Resubmission, Renewal, Continuation or Revision application, enter the agency award number • NIH requires the format CA012345 • For a Changed/Corrected application - enter the Grants.gov tracking number • Item 5, Applicant Information • This information is about the applicant organization (UMB)not the PI • Use ORD’s mailing address: 660 West Redwood St, rm 021 • Organizational DUNS: 188435911

13. SF424 (R&R)— Cover Page • Item 8, Type ofApplication--New Terminology • New = New • Resubmission = Revision (a revised or amended application) • Renewal = Competing Continuation • Continuation = Non-competing Continuation/ Progress Report NIH is not using Grants.gov for Non-Competing continuation applications at this time • Revision = Competing Supplement • Terminology cross-walk provided in NIH instructions • Item 15 - PI information • For Multi-PI applications, list the Contact PI here • Department = Department • Division = School

14. SF424 (R&R)— Cover Page • Item 16, Estimated Project Funding • Must type in amounts (i.e. not automatically generated from budget form) • 16a = Total Direct and F&A Costs for all project years • 16b = Amount in 16a + cost sharing for all project years • Usually 16a and 16b are equal since cost sharing is rarely required or approved • 16c = Program income (if applicable) • Item 17, E.O. 12372 Process • FO will indicate if the program is subject to this EO (doesn’t apply to most NIH programs) • Item 19, Authorized Representative • ORD contact person

15. SF424 (R&R) Cover Page Page 2 (items 16-20)

16. PHS 398 Cover Page Supplement • Companion form to the SF424 (R&R) Cover Page (PD/PI info at the top is pre-filled) • Data fields for: • New Investigator • PI Degree(s) • Clinical Trial, Phase-III defined clinical trial • Human Embryonic Stem Cells information • Captures the title and mailing address of the Business Official Contact (ORD)

17. PHS 398 Cover Page Supplement Page 1

18. PHS 398 Cover Page Supplement Page 2

19. Research and Related Project/Performance Site Locations • Document accommodates up to 8 performance sites • Additional performance site information must be provided in an attachment • Format for this attachment is available on SF424 (R&R) Forms Page: http://grants.nih.gov/grants/funding/424/index.htm

20. Project/Performance Site Locations

21. Research and Related Senior/Key Person Profile • Captures personal profile information on the PD/PI, Key Personnel, and Other Significant Contributors • Credential: Must enter the eRA Commons UserID for the PD/PI (for all PIs in Multiple-PI applications) • mandatoryfield for NIH applications • Field is circled on the slide

22. Senior/Key Person Profile (Expanded)

23. Research and Related Senior/Key Person Profile • Role: • PD/PI is the role of the Principal Investigator, or all PIs for a Multiple PI application • For Multiple PI appliations, the Lead PI is listed first, then the other PI(s), followed by other Key Personnel • For NIH - DO NOT use the role “Co-PD/PI” - NIH does not use this role. • In the dropdown menu there is a role of “Other” - use the field to enter an appropriate role such as “Co-investigator”, “Biostatistician”, “Nurse Coordinator” and the like • List Other Significant Contributors after Key Personnel

24. Research and Related Senior/Key Person Profile • Attach Biosketch for each person • 4 pages, including positions & honors, selected publications, and research support • Use the format available at http://grants.nih.gov/grants/funding/424/index.htm • If required, attach Current & Pending Support • Not required by NIH at time of application unless specified in FOA (collected Just-in-Time instead) • Other agencies may require at time of application

25. Senior/Key Person Profile (Expanded) Additional Senior/Key Person Form Attachments

26. Version 2A: Research & Related Senior/Key Person (Expanded) • Enter Senior/Key Person 1, click the Next Person button to display the fields for Profile – Senior/Key Person 2. • After the first 8 are entered (PI + 7 others), the Select to Extract the R&R Additional Senior/Key Person Form button becomes active. • Click to open a new page to “extract” a form to add information for up to 8 more individuals. You may prepare four such forms, thus allowing up to 40 Senior/Key Persons.

27. Senior/Key Person Profile (Expanded) Additional Senior/Key Person Form Attachments Clicking on the “Select to Extract the R&R Additional Senior/Key Person Form” button produces the PureEdge form shown above.

28. Senior/Key Person Profile (Expanded) • Save each “extracted” form separately on your computer as you enter data and upload biosketches. These will be .xfd (PureEdge) files. • Then, when complete/final, upload the additional Senior/Key Person form(s) to the portion of the Senior/Key Person Profile called “Additional Senior/Key Person Form Attachments” • For additional individuals (>40), use a .pdf attachment. This attachment is uploaded at the bottom section of the “Additional Senior/Key Person Form Attachments” page, along with biosketches. The button to add this attachment activates only after 40 individuals have been entered in the other forms. • Format for this pdf attachment is available on SF424 (R&R) Forms Page: http://grants.nih.gov/grants/funding/424/index.htm

29. Upload completed Senior/Key Person forms (.xfd) here Upload information for >40 Senior/Key Persons (.pdf) here

30. Research and Related Other Project Information • Captures information on use of Human Subjects, use of Vertebrate Animals, Environmental Impact, Foreign Involvement

31. Other Project Information

32. Research and Related Other Project Information • IRB Human Subject Assurance Number is 00007145 • Questions 1a and 2a (IRB/IACUC Pending?): Respond “No” only if the protocol is approved and you can provide an approval date. Respond “Yes” for pending and “to-be-submitted” protocols

33. Research and Related Other Project Information • Includes upload buttons for separate PDF attachments: • Project Summary/Abstract • Project Narrative • “Relevance” section of the PHS398 Abstract • Using no more than two or three sentences, describe in lay terminology the relevance of this research to public health. • Bibliography & References • Facilities & Other Resources • Do not use the old form from the PHS398 application • Include facilities information from any proposed subrecipients • Equipment resources • Include equipment information from any proposed subrecipients

34. PHS 398 Research Plan • Requires separate PDF attachments for each section • For each, include a section heading as part of the text; i.e., Specific Aims, Background & Significance • Follow same formatting requirements as in the PHS398 • Font, margins, page limits, etc. • Check FO for page limits • Create the Research Plan (Specific Aims, Background/Significance, Preliminary Studies/Progress Report, Research Design/Methods) as one document to meet the page limitation, then divide into sections and convert to pdf • If your research involves human subjects or animals, upload the required attachments • Letters of Support: Should be signed and on letterhead; scan, creating one pdf file

35. PHS 398 Research Plan

36. PHS 398 Research Plan • Resource sharing • All applications where the development of model organisms is anticipated must address the sharing of unique model organisms • http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html • All investigator-initiated applications requesting >$500,000 direct costs in any year or when specifically required by the FO must address data-sharing. • http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-035.html • Appendix Material • Captures up to 10 separate attachments • Accessible only to appropriate NIH staff and peer reviewers • Not included in the application grant image in eRA Commons • Follow NIH’s new policy for including publications as appendices: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html

37. Budget Forms • Prepare EITHER the PHS398 Modular Budget form OR the Research & Related Budget form • Modular budgets are applicable to certain research grant applications (R01, R03, R15, R21, and R34) requesting $250,000 or less per year for direct costs.

38. PHS 398 Modular Budget • Captures data for each budget period: • A. Direct Costs • Direct Costs excluding Consortium F&A • Consortium F&A • Total Direct Costs • B. Indirect (F&A) Costs • F&A base x rate = F&A Costs(like the current Checklist page) • Total Costs (A + B) • Cumulative Budget is system-generated

39. PHS 398 Modular Budget

40. PHS 398 Modular Budget • 3 Possible Budget Justification attachments: • Personnel (required) • Roles and person months (a.k.a. effort) • Consortium (if applicable) • Institution name, roles and person months, annual total costs (round to nearest $1000) • As in the past, the institutional sign-off, SOW, detailed budget and justification for subrecipients is still required for internal purposes, but NOT submitted to NIH • Other (if applicable) • Used only if there is a variation in the number of modules requested in a given period

42. Research and Related Budget, Sections A & B • Personnel separated into 2 sections • A. Senior/Key Person • Lines for 8 named individuals • Information for additional individuals must be provided in an attachment • Info for PD/PI must be entered even if $ = 0 • B. Other Personnel • Postdocs, Technicians, Research Associates, Grad Students, Undergrads, etc • Captures number of individuals instead of names • NIH requires detail about all personnel in Budget Justification (e.g. names, person months, roles, etc.)

43. R&R Budget Sections A & B

44. Research and Related Budget, Sections C - E • C. Equipment • Captures up to 10 items • Insert total cost of additional items in line 11 and provide the details in an attachment • D. Travel • Captures Domestic & Foreign travel costs separately • NIH will continue to award as a single category • E. Participant/Trainee Support Costs • Captures data for Programs using this budget category (e.g. NSF’s REU program) • Not used for NIH applications unless specifically noted in FO

45. R&R Budget Sections C - E

46. Research and Related Budget, Sections F - K • F. Other Direct Costs • Captures Supplies, Publication Costs, Consultants, ADP/Computer Services, Consortium Costs, Equipment or Facility Rental/User Fees, Alterations & Renovations • Item F.5 - Total of all subaward for that project year • Use items 8 - 10 for patient care costs, subject payments, tuition remission, etc. • G. Total Direct Costs (A – F) • H. Indirect Costs (F&A) • I. Total Costs • J. Fee (Not applicable to UMB) • K. Budget Justification—a PDF text attachment, addressing all project years

47. R&R Budget Sections F - K “Next Period” button activates after required data have been entered and budget justification has been attached. Budget justification covers all periods and is attached once, at section K of budget period 1

48. Research and Related Budget, General Notes • Form requires a detailed budget for every budget period • Click Next Period Button to create budget document for the next budget period (see previous slide) • All required data fields in this component must be entered for Budget Year 1 before this button is available. This includes the Budget Justification. • Data from prior budget period does not carry-forward to next period form; must be re-entered • A detailed cumulative budget is system-generated

49. R&R Subaward Budget Attachment Form • Captures detailed budgets from proposed subrecipient institutions • Up to 10 separate budget attachments • One for each subrecipient institution • >10 subrecipients: For NIH, if there are more than 10 subrecipients, budgets 11 and above should be converted to PDF and included as part of Section K (Budget Justification).