Disclosure I do not have any relationship(s) with commercial interests.

1. LSU School of Medicine-New Orleans (LSUSOM-NO) is the provider of Continuing Medical Education for this activity. The planning and presentation of all LSUSOM-NO activities ensure balance, independence, objectivity and scientific rigor. The LSU School of Medicine-New Orleans designates this educational activity for a maximum of 1.5 AMA PRA Category 1 Credit(s) ™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. LSUHSC-NO ORS Training Series

2. Disclosure I donothave any relationship(s) with commercial interests. A commercial interest is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients. LSUHSC-NO ORS Training Series

3. Grants.gov:Submitting anNIH Grant Application

4. Welcome • Presenter: • Nicole G. Hammill, MBA • Coordinator of Grants and Development • Office of Research Services • Nbarro@lsuhsc.edu • (504) 568-4970 tel • (504) 568-8808 fax • http: www.lsuhsc.edu/no/administration/rs/GrantsContractsProcessing.htm LSUHSC-NO ORS Training Series

5. Agenda • Overview • What is Grants.gov? • What is eRA Commons? • Preparing to Apply • Creating an Application • Submitting an Application • Checking an Assembled Application • Lessons Learned • Overview (Review) • Questions and Answers LSUHSC-NO ORS Training Series

6. Helpful Administrative Information • Most of the numbers, dates, names, and titles commonly needed for administrative purposes can be found here: http://www.lsuhsc.edu/no/administration/rs/Helpful_Administration_%20Information.pdf LSUHSC-NO ORS Training Series

7. Overview LSUHSC-NO ORS Training Series

8. Overview LSUHSC-NO ORS Training Series

9. What is Grants.gov? • Federal government’s single online portal to find and apply for federal grant funding • Used by all federal grant-making agencies • LSUHSC-NO is already registered • Individual investigators do not register in Grants.gov LSUHSC-NO ORS Training Series

10. What is eRA Commons? • NIH electronic research administration system that allows applicants/grantees to electronically receive and transmit application and award information • Used by NIH and other HHS components (CDC, AHRQ) • LSUHSC-NO is already registered • Individual investigators do need a Commons account! • Commons accounts are established by Office of Research Services personnel LSUHSC-NO ORS Training Series

11. Preparing to Apply • Arrange for establishment of Commons account • Contact Office of Research Services • Investigators have one account that follows them throughout their careers; the same account may be “affiliated” with multiple organizations • Office of Research Services can “affiliate” existing account with LSUHSC-NO • Vital that information in investigator’s Commons profile is current and accurate • Allow 4-5 business days for Commons account to be established (usually happens very quickly) LSUHSC-NO ORS Training Series

12. Preparing to Apply • Procure software • Grants.gov offers free Adobe software: http://www.grants.gov/help/download_software.jsp • Most LSUHSC-NO departments have latest version of Adobe software • Investigators are responsible for ensuring the version of Adobe used is compatible with Grants.gov. Check here: http://www.grants.gov/help/download_software.jsp#adobe811 • In most cases, a pop-up warns users if they are using the wrong version of Adobe. Using the wrong version can corrupt an application. LSUHSC-NO ORS Training Series

13. Preparing to Apply • Select a Funding Opportunity Announcement (FOA) • Since all applications must be submitted in response to an FOA, the NIH has created “parent” FOAs for Investigator-Initiated Research • Apply using the “parent” electronic application package for your chosen award mechanism (R01, R03, etc.) • NIH parent announcement page is here: http://grants.nih.gov/grants/guide/parent_announcements.htm • FOAs are also issued for non-investigator-initiated projects LSUHSC-NO ORS Training Series

14. Search for specific (non-investigator-initiated) FOAs here Find “Parent” FOAs here LSUHSC-NO ORS Training Series

15. Select the FOA number to open the announcement LSUHSC-NO ORS Training Series

16. Preparing to Apply • Download FOA application package and instructions • Once appropriate FOA has been selected, click the “Apply for Grant Electronically” button • This will take you directly to Grants.gov so you may download both the application package and its accompanying instructions • Be sure to fill out box to receive e-mails if changes to FOA occur • Note that you cannot submit the application until the “opening date” shown on the FOA • Note that any instructions in the FOA take precedence over the general instructions found in the Grants.gov application guide. • The applicant must complete the application using the package attached to that particular FOA. Information from the specific FOA is used in the forms. • Applicants cannot use any sample form packages or form packages from other FOAs. • The applicant will complete data entry in all necessary components and upload appropriate attachments. LSUHSC-NO ORS Training Series

17. Note: you cannot apply until the “open date” shown in the FOA Important: the instructions in the FOA take precedence over the Grants.gov application guide. Within the FOA, click the “Apply for Grant Electronically” button. LSUHSC-NO ORS Training Series

18. Imperative that correct, most recent version of FOA is used; use of older versions will not be accepted. Look for “FORMS-C” LSUHSC-NO ORS Training Series

19. Important tip: Sign up to receive notification of changes to the FOA! Download the application form and its instructions from this location. LSUHSC-NO ORS Training Series

20. Select “save” to save the application to your local hard drive, network drive, etc. LSUHSC-NO ORS Training Series

21. Preparing to Apply • Route materials through Office of Research Services • At least 10 working days in advance of an application deadline, PIs should route through the Office of Research Services: • A double-sided yellow routing sheet (formatted as an Adobe PDF document or as a Worddocument) completely filled out and signed by the PI, Business Manager, and Department Head • Routing sheets must be printed on yellow paper. • Routing sheets without keywords will be returned without review. • Routing sheets must contain information on regulatory (IRB / IACUC / IBC, etc.) approvals (if applicable). • A project abstract • A draft is acceptable, but the abstract should reflect the entire proposed scope of work. • A face page (including a signature line for institutional official) LSUHSC-NO ORS Training Series

22. Preparing to Apply • A budget • Budgets should include information on how F&A (“indirect”) costs were calculated. • A budget justification • Sponsor's official written policy on F&A costs (if sponsor will not pay current federally-negotiated rate) • A letter or e-mail from the sponsor merely saying that they will not pay full F&A is not sufficient to request a waiver of F&A cost recovery. • If the sponsor does not have an official written policy on F&A costs, and is not willing to pay the current federally-negotiated rate, include a letter to the Authorized Institutional Official requesting that F&A costs be waived (be aware that the request may or may not be granted). • Please see Permanent Memorandum 10 (http://www.lsuhsc.edu/administration/pm/pm-10.pdf) for more information on Indirect Cost Allowances on Grants and Contracts. LSUHSC-NO ORS Training Series

23. Preparing to Apply • Letters of Intent to Establish a Consortium Agreement • These letters are required if a prime/sub relationship is proposed (the sub should sign first). • Investigators are not authorized to release information to prime applicants until materials are reviewed and approved. • SBIR/STTR letter(s) (if applicable) • All documents necessary to comply with CM-35 LSUHSC-NO ORS Training Series

24. Creating an Application • Complete application package • Application components include specific data fields as well as multiple attachments • Most attachments are text • NIH requires .pdf text attachments • Other sponsors who use Grants.gov may not require .pdf attachments; nevertheless, get into the habit of converting all attachments to .pdf • Create attachments using any word processing software but convert to .pdf before attaching to the application form • Do not include headers or footers in the text pages • Details on creating an application will be provided in a separate session, entitled “NIH Application Forms” LSUHSC-NO ORS Training Series

25. Submitting an Application • Transmit the application to the Office of Research Services after receiving word that paperwork has been signed • Only the institution’s “Signing Official” (aka “SO” or “AOR”) is authorized to click the “submit” button • Nicole Hammill and Dr. Kenneth Kratz are authorized to act on behalf of the Signing Official • It is the investigator’s responsibility to transmit the completed application package to the Office of Research Services well in advance (at least 5 working days) of the deadline. • Acceptable means of transmission include: • E-mail (by far the most popular method) • CD/DVD • Flash Drive • Requests for submission should include a notation that the budget, abstract, etc. have already been approved in writing LSUHSC-NO ORS Training Series

26. Submitting an Application • Confer with Office of Research Services personnel about required corrections and modifications to application package • Correct/modify the application package, and re-transmit to the Office of Research Services for submission via Grants.gov. • The Office of Research Services cannot and will not make modifications to an investigator’s application package. LSUHSC-NO ORS Training Series

27. Submitting an Application • Await series of e-mail notifications from both Grants.gov and eRA Commons • These will be forwarded to the investigator fromthe Office of Research Services • Do not leave the country or otherwise become unavailable until all e-mail notifications have been received! • E-mail notifications will be sent to all principal investigators and to the “department contact” named on the yellow routing sheet (generally the departmental business manager and/or grants coordinator). • Expected system response times: • Grants.gov: generally within hours, up to 2 weekdays • In rare instances, Grants.gov can take longer to respond. Example: submission of “Recovery Act” applications • Commons: generally within hours, up to 1 weekday • Note that “weekdays” include holidays LSUHSC-NO ORS Training Series

28. Submitting an Application • Grants.gov performs “validations” to ensure that: • All mandatory fields have been completed • All mandatory documents have been completed and moved to the Completed Documents box • The DUNS number is correct • The date formats and e-mail formats are correct • No viruses are present • E-mail notifications from Grants.gov are: • Submission Receipt – application received and is being validated • Rejection Notice – application is not validated because of Grants.gov errors • Submission Validation Receipt – application has been validated • Grantor Agency Retrieval Receipt – application has been received by the agency/sponsor • Agency Tracking Number – application has been assigned a tracking number by the grantor agency/sponsor LSUHSC-NO ORS Training Series

29. Submitting an Application • eRA Commons performs “validations” to ensure that: • Instructions in Grants.gov application guide have been followed • Instructions in the specific FOA have been followed • Institutional information provided in the application matches institutional information on file • A detailed list of Commons validations is available here: http://grants.nih.gov/grants/electronicreceipt/files/SF424RR_Validation.pdf. • E-mail notifications from Commons are: • Validations Complete/Check Assembled Application: Commons has completed its validation process and the assembled application is ready for viewing • Action Required: Commons has attempted to validate the application, but errors were encountered that must be addressed • SO has refused electronic application: Commons has received a request from the institution’s signing official to halt processing of an application LSUHSC-NO ORS Training Series

30. Submitting an Application • View errors and/or warnings • Errors must be addressed before the application can move on to NIH receipt & referral • Warnings may be fixed at the applicant’s discretion, but do not require action for the application to move on • In most cases, warnings can be ignored LSUHSC-NO ORS Training Series

31. Click the “status” tab in Commons to view application status Follow “Show All Prior Errors” link to view both warnings and errors <Obscured to protect PI privacy> LSUHSC-NO ORS Training Series

32. Sample Warning Remember, warnings can generally be ignored LSUHSC-NO ORS Training Series

33. Sample Error Errors must be corrected! LSUHSC-NO ORS Training Series

34. Submitting an Application • To correct errors: • Log into Commons and locate your application. • Review error conditions that were identified during validation. • Within your application (the same file that you sent to the Office of Research Services for submission), make whatever corrections are necessary, wherever appropriate. • Check the “Changed/Corrected Application” box in block 1 of the SF424 (R&R) Cover component. • When you check the Changed/Corrected Application box, Item 4C, “Previous Grants.gov Tracking ID” becomes a required field. • In Item 4C, enter the Grants.gov tracking number for the previous application that you are correcting. • Do not use the Changed/Corrected Application box to denote a submission of a revised or amended application. That will be indicated in item 8, Type of Application. LSUHSC-NO ORS Training Series

35. Submitting an Application • Transmit the corrected application package back to the Office of Research Services for another attempt. • The application will only be assigned for scientific review once errors are resolved. • Important: if corrections are submitted after the due date/time, include an explanation about why the application is late in the Cover Letter Component. • The NIH is never under any obligation to accept a late application – submit a late application only at your peril! See: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-11-035.html. LSUHSC-NO ORS Training Series

36. Submitting an Application • To address warnings: • In most cases, warnings can be ignored and no action should be taken • If warnings are corrected, process is identical to process for correcting errors LSUHSC-NO ORS Training Series

37. Checking an Assembled Application • Review entire application • Assuming no errors were detected, the eRA Commons system will: • Assemble the grant image • Generate a table of contents • Include headers (PI name) and footers (section name, page numbers) on all pages • Imprint the Grants.gov tracking number, FOA number, and date/time on each page • Application not considered received by NIH until you see the application image in Commons • If you can’t see it, the NIH can’t see it either LSUHSC-NO ORS Training Series

38. <Obscured to protect PI privacy> View the application image by clicking on the Application ID LSUHSC-NO ORS Training Series

39. Then, click on the e-Application link to view the image LSUHSC-NO ORS Training Series

40. Be sure to review entire application carefully; your application is not considered received by the NIH until you see this image in Commons LSUHSC-NO ORS Training Series

41. Checking an Assembled Application • If errors in the “translation” between Grants.gov and Commons are discovered, it is possible to request that SO “reject” the application • SO has a 2 weekday viewing window to reject an application that has system formatting errors • If the application is not rejected within the 2 weekdays it will automatically proceed to Receipt & Referral • Weekdays include holidays • The option to ask the SO to “reject” the application should be used cautiously, and only to correct system formatting problems. It should not be used as an opportunity for PI to make additional changes to application. • As the NIH states, “the AOR/institution is expected to enforce that application changes made within the window are restricted to those necessary to address system-identified errors/warnings. NIH may reject any application that includes additional changes.” • Once rejected, follow the steps for correcting errors described previously LSUHSC-NO ORS Training Series

42. Lessons Learned • Work closely with: • Your Departmental Administration: Be sure you’re aware of departmental policies, procedures, and deadlines. • The Office of Research Services to ensure a streamlined internal process flow (review, approval, document sharing, etc.) • Register now to be prepared • All PIs, fellows, postdocs, and graduate students need to be registered in eRA Commons • Read and follow all instructions in the FOA and in the Application Guide: • http://grants.nih.gov/grants/funding/424/#inst LSUHSC-NO ORS Training Series

43. Lessons Learned • Beware of the most common mistakes: • All attachments must be in .pdf format • File names should: • Contain no more than 50 characters • Include no “special characters”, such as dashes or the “&” symbol • The .pdf files should not be write-protected • Each attached .pdf, as well as the overall application file, should be virus-checked • Include the PI’s “credential” in the personnel section. This is his or her Commons ID. • A comprehensive list of frequently-seen errors and warnings is available here: http://www.lsuhsc.edu/no/administration/rs/Commons%20errors%20and%20warnings.pdf LSUHSC-NO ORS Training Series

44. Overview (Review) LSUHSC-NO ORS Training Series

45. Overview (Review) LSUHSC-NO ORS Training Series

46. Questions and Answers

47. Thank You!