Proposal submission to NIH via Grants

1. Proposal submission to NIH via Grants.gov Overview of NIH eSubmission and Internal Routing Processes Includes Review and Submission of a Changed/Corrected Application Updated June 2007

2. Getting started Overview Funding Opportunity Announcements Software requirements

3. Grants.gov and NIH • Grants.gov • is being used by 26 Federal grant-making agencies • Is a web-based portal that facilitates finding grant opportunities and applying for funding • Grants.gov electronic submission is already required for a number of NIH mechanisms including R01 applications • Once a mechanism transitions to Grants.gov, paper submissions are no longer permitted • Noncompeting continuation applications (progress reports) will continue to be submitted in hard copy or via eSNAP (NIH eRA Commons)

4. Getting Started • DO NOT register on Grants.gov or in CCR - the University is registered as an institution • ORD staff are registered as Authorized Organizational Representatives (AORs)

5. Getting started • Faculty applying for NIH grants must register in NIH eRA Commonshttps://commons.era.nih.gov/commons/ • If you have a username from a prior institution, you must affiliate with UMB • If you have a username because you are a reviewer, you must set up a different account as a PI • Contact Colin Hunter (chunter@umaryland.edu) regarding NIH eRA Commons accounts • The PI will also need a login for the web-based routing form • PIs may request username and login online via the link at: https://ord2.umaryland.edu/uom/index.lasso

6. Software • Download “PureEdge Viewer” - free via the Grants.gov website • http://www.grants.gov/PEViewer/ICSViewer602_grants.exe • Grants.gov Grant Application Packages can only be viewed and completed with PureEdge Viewer • Mac/Non-Windows users will also need to purchase Windows emulation software or check the NIH and Grants.gov site for other options • http://era.nih.gov/ElectronicReceipt/files/mac_options.htm • Contact Colin Hunter for additional Mac expertise chunter@umaryland.edu • Ensure that you have software to create PDF files from Word or other word processing applications • SOM: obtain Adobe software (~$50) through the Dean’s Office - Sharon Bowser, 6-0412

7. Finding the application package • You must locate a “Funding Opportunity Announcement” for ANY and ALL NIH electronic submissions • The Grant Application Package is specific to the NIH mechanism (R01, R21, etc) even if you are submitting a new general, investigator-initiated application or a Renewal application, Resubmission (formerly known as revised or amended) application • Program Announcements (PA) and Requests for Applications (RFA) still exist - and you must download the specific Grant Application Package for each PA or RFA

8. Where to look • Find out what mechanisms have transitioned to electronic submission http://era.nih.gov/ElectronicReceipt/strategy_timeline.htm • Search for NIH grant opportunities via the NIH Guide for Grants and Contracts http://grants.nih.gov/grants/guide/index.html • The NIH now refers to the general, investigator-initiated (unsolicited) program opportunity as the “PARENT” - eg “Parent R01”:http://grants.nih.gov/grants/guide/parent_announcements.htm

9. The Grant Application Package • When you identify the right Program Opportunity Announcement, click on the “Apply for Grant Electronically” button within the program announcement to download the PureEdge Grant Application Package for that announcement. • You must download the Grant Application Package for each specific Funding Opportunity Announcement (FOA) • For example, the Grant Application Package downloaded from an R03 FOA may not be used for an R01 application • Always check for an updated version, i.e., do not use an older R21 Grant Application Package that was downloaded for a prior deadline

10. Finding the application package • For Resubmissions (amended/revised applications) of application submitted in response to a specific Program Announcement - check to determine whether the PA is still active. When in doubt, contact the Program Officer. Download either the Grant Application Package from the current PA, or use the Parent announcement and refer to the prior PA in a cover letter. • Note - search for grant opportunities from other Federal agencies using the “Find Grant Opportunities” area of Grants.gov http://www.grants.gov/applicants/find_grant_opportunities.jsp

11. PureEdge Files and File Sharing • PureEdge Grant Application Packages are like Word documents - • The Grant Application Package document must be saved on a local hard drive, server, etc - it is NOT a web-based system • Only one person can work on the document at a time • Adding information or editing must be done sequentially in the same document • PIs and their administrators need to discuss how the Grant Application Package will be shared for completion and review, and who will complete the fields in the forms, upload attachments, etc.

13. Saving and sharing the file • Save the downloaded Grant Application Package on your computer for completion • The Grant Application Package needs to be saved on your local hard drive, server, USB drive, etc. • You will get a warning message when you first save the package from the FO because no data have been entered yet • You will continue to get this message each time you save until all required data are entered • OK to ignore message until ready to submit • Re-save as you add information (similar to working with a Word document - save early and often!) • When you Save, be careful with the file name and location (avoid creating multiple versions in various places). • PureEdge files have an .xfd extension

14. Instructions! • When you download the Grant Application Package, download any accompanying Instructions. • Keep your Funding Opportunity Announcement (program announcement or request for applications) handy for reference - this document normally includes information about required forms and attachments as well as page limitations • Follow any links within these documents for additional information (for example, information specific to an NIH institute) • The “Grants.gov Application Guide SF424 (R&R)” is invaluable and may be downloaded from: http://grants.nih.gov/grants/funding/424/index.htm

15. Internal Routing and Review Timelines Routing requirements Review in ORD Validations by Grants.gov and NIH

16. When it’s time to submit • Electronic submission through Grants.gov means that PIs no longer submit the application to NIH or other Federal agencies: this is now ORD’s responsibility. • Therefore, ORD needs the FINAL - READY TO SUBMIT version of your PureEdge file well before the actual agency deadline

17. Grants.gov Submission and Retrieval Your Grant Application Grants.gov Federal Agency Submitted by ORD via web interface Application retrieved from Grants.gov by Agency

18. Submission Timeline FINAL PureEdge file to ORD 3 to 5 days Review Receipt Validation Retrieval Errors/Warnings? Resubmission Deadline Proposal submission

19. Grant Routing Policies • The School of Medicine has implemented a grant routing policy - other schools have similar policies • Hard copy of application with routing form should be submitted to the Dean’s Office 7 business days before the deadline • By 5 business days before the deadline, the signed routing form should be provided to ORD, AS WELL AS the completed electronic grant application in FINAL form (the completed PureEdge file with final attachments) • The web-based routing form is required for routing all applications and facilitates transmission of PureEdge application packages https://ord2.umaryland.edu/uom/index.lasso

20. Save form data and send PDF: instructs the program to send Routing Form pdf to PI and other contact person to be printed out for routing. Screen shot of routing form

21. Hard copy - Routing Form and required Attachments • Attach detailed budget spreadsheet (include personnel names and percent effort/person months) • Attach a DRAFT of the research plan • If your application includes subcontractors, you must also attach documentation of organizational sign-off from the subrecipient • SOM: If your application includes human subjects or involves use of animals in the research, attach those portions of the research plan as well as a print-out of the completed “Other Project Information” form from the Grant Application Package • The next slide shows the form and the Print button to print that form only.

22. Check “Yes” for pending or to-be-submitted protocols

23. Routing Form - Upload Attachments (Web-based form) • While the hard copy is in the routing process, put the final touches on your application and upload the FINAL completed PureEdge file to the existing routing form • Do not create a new routing form - use the “View, Edit” link to identify the routing form for this project, open that form, and upload the file • Email or call your ORD contact person to advise that the FINAL file has been uploaded for ORD review.

24. Click on View, Edit Routing Forms (circled) to access an existing routing form. Then, click on “Upload Files”.

25. Upload the Budget, the PureEdge Grant Application Package, and other relevant documents

26. Routing form & print-out of budget, draft proposal Routing for signatures PI/Dept prepare application forms & attachments Grants.gov review/ validation Agency receipt/ error check ORD review ORD submits application PureEdge Application Packet Upload to web-based Routing Form Resubmission, when required

27. Your Routing and ORD • After signature at the Dean’s Office, the signed routing form and hard copy attachments are delivered to ORD and logged in. • The application is assigned to a Contract & Grant Officer for review, normally to the individual assigned as the primary point of contact for your department or division. • After you notify ORD that the PureEdge file has been uploaded to the routing form, ORD accesses the file via its database

28. ORD Review • ORD reviews the budget and administrative parts of the application, focusing on requirements (e.g., mandatory attachments, page limits). • ORD verifies that fields are completed and that attachments are in PDF format, as required by NIH.

29. ORD Review • ORD notifies the PI and administrator of any concerns. Work with your ORD point of contact to determine the most expedient way to make the required corrections. • ORD can make minor corrections to data in the form fields. • ORD cannot correct or change the content of PDF file attachments.

30. Revised PureEdge Files • If substantive changes are needed, ORD may request that the department/PI provide a corrected PureEdge file to ORD. • Upload the corrected PureEdge file to the existing routing form, and contact ORD to advise that the file is available. • To minimize confusion, ORD requests that you give the revised PureEdge file a new file name (such as “SmithR03Version5.xfd”)

31. Validations and eSubmission • A key to successful submission is meeting the validation standards set by Grants.gov and NIH eRA Commons • Computer programs check for completion of mandatory fields and inclusion of mandatory attachments, including page limits • Use checklists and instructions to help minimize errors and warnings

32. Errors and Warnings • A validation Error means that the submission is not successful and the application will not go forward in the review process • A validation Warning means that the computer found some inconsistency that you should check, but the application will move forward for further review

33. “Check package for errors” • The Check Package for Errors button (circled on the next slide) in the PureEdge Grant Application Package will ONLY show Grants.gov errors. • We must Submit the application for it to go through the NIH validation process. NIH errors will be shown in the eRA Commons. • Use our checklist and tips to avoid NIH validation errors

34. This button only catches Grants.gov errors - not NIH validation errors

35. Submission and Validation • ORD submits the application through Grants.gov • A confirmation page is provided on the website, then at least four email messages begin to arrive. ORD forwards Grants.gov emails to the PI and Administrator • Grants.gov receipt • Grants.gov validation • Agency retrieval • Agency tracking number assigned • NIH Commons emails regarding submission status are sent to the PI and ORD. These messages advise of the result of the NIH validation process and whether the application has been assembled for viewing in NIH Commons. • These notifications have taken anywhere from minutes to days

36. Errors, Warnings and Corrections • An application with an ERROR will not go forward for review (and will not be available to view in NIH Commons) • Applications with Errors should be corrected and resubmitted via Grants.gov prior to the agency deadline • Review and correct Warnings as required. Applications with Warnings will go forward for review. Corrected/changed applications should be resubmitted via Grants.gov prior to the agency deadline. • Most Warnings have been minor and have not required correction/resubmission. • Avoid some Warnings by ensuring that PIs and Key Persons have updated their data in the eRA Commons Personal Profile

37. What will a completed NIH application look like? • After successful submission with no NIH validation Errors, the eRA system will: • Assemble the grant image (pdf document) • Generate a Table of Contents • Insert headers (PI name) & footers (page numbers) on all pages • Cover letter and Appendices are separated from the rest of the application, and no headers or footers are inserted on those documents. • The Institutional Signing Official (ORD) and the PI can review and verify the grant image in the eRA Commons

38. Review in Commons • NIH allows 2 business days for the PI and Signing Official (SO) to review the application in eRA Commons, during which time the SO may reject the application. • This option may be used if the PI or SO determines that warnings should be addressed, but should be avoided if possible • If the application is rejected, a changed/corrected application must be submitted within the two day viewing window. • If no action is taken within the 2-day period, the application will automatically move forward in the NIH review process.

39. Corrected Applications • Prior to the submission deadline, the AOR/SO can reject the application and submit a changed/corrected application to Grants.gov before the submission deadline. No cover letter is needed.

40. Corrected Applications • If the AOR/SO rejects the application after the submission deadline to address warnings, the AOR/SO can submit a changed/corrected application within the one week correction window NIH is allowing during the transition. A cover letter must be attached to the application package, explaining the reason for the delay. • If the AOR/SO rejects the application after the submission deadline for some reason other than system issues or warnings, a changed/corrected application can be submitted to Grants.gov. But applicants need to be cautioned that these applications will be subject to the NIH late policy and may not be accepted. A cover letter must be attached to the application package, explaining the reason why the application is late.

41. Resources • NIH application instruction guide(s) http://grants.nih.gov/grants/funding/424/index.htm • NIH Grants Info • Phone: 301-435-0714; 301-451-0088 (TTY) • Email: GrantsInfo@nih.gov • http://era.nih.gov/ElectronicReceipt • NIH - Avoiding Common Errors http://era.nih.gov/ElectronicReceipt/avoiding_errors.htm • ORD • Phone: 410-706-6723