NIH Grants Proposal Development

1. NIH Grants.gov Proposal Development

2. Getting Started • Registration – OSPRA has registered in Grants.gov on behalf of the University. PI’s do not need to register in order to download and prepare an application package. • Adobe compatibility - A compatible version of Adobe Reader is required (Adobe Reader 8.1.2 or higher is recommended) for anyone who will participate in the preparation of the proposal. Grants.gov offers a tool that will verify whether you have an acceptable version of Adobe installed on your computer. The link to this tool is: http://www.grants.gov/applicants/AdobeVersioningTestOnly.jsp

3. Getting Started What is the SF424 (R&R)? • Stands for Standard Form 424 – Research and Related. • Is a combination of separate forms focusing on the many aspects of a proposed grant. • Is used government-wide • Used by 15 different Federal agencies • Based on overall needs of the agencies, not tailored to specific agencies, funding opportunities or grant programs • Agency-specific forms are allowed where appropriate • A complete application to the NIH will include a combination of R&R and PHS 398 components.

4. Getting Started • The applicant must complete the application using the package attached to the specific Funding Opportunity Announcement (FOA). • Sample forms or forms from other FOA’s should not be used.

5. Preparing an Application Components of Applications to NIH or Other PHS Agencies • Required Components • SF424 (R&R) Cover • SF424 (R&R) Project Performance Site Locations • SF424 (R&R) Other Project Information • SF424 (R&R) Senior/Key Person Profile(s) • SF424 (R&R) Budget (unless using PHS398 modular budget) • PHS398 Modular Budget (unless using SF424 (R&R) budget) • PHS398 Cover Page Supplement • PHS398 Research Plan • PHS398 Checklist

6. Preparing an Application • Optional Components • SF424 (R&R) Subaward Budget Attachment Form - may be required under specific circumstances. • PHS398 Cover Letter - may be required under specific circumstances.

7. Tips for Successfully Preparing and Submitting an Application • Make sure that the PD/PI is registered (a one time process) in the NIH eRA Commons at least two weeks in advance of the deadline.No registration is required in Grants.gov. Consult the OSPRA website for registration information http://www.ospra.uiuc.edu/faq.html • Review the Funding Opportunity Announcement thoroughly before beginning and familiarize yourself with the NIH Grants.gov application guide. • Complete the SF 424 R&R cover sheet first – it populates fields in several other forms. • Make sure to complete all mandatory documents and fill in all mandatory (yellow) fields. In addition, make sure that all fields that are mandatory to NIH are completed. • Consult the SF424 R&R Application Guide for NIH for guidance. It is a valuable resource. • Hover over help is available for many fields. • Do not recycle previously submitted applications or use sample applications. • Make sure that all attachments are in PDF format. • Provide OSPRA with the final version of the application at least five days prior to the deadline.

8. Let’s complete an application!

9. Preparing an Application Accessing the Application Package • The Grants.gov application package may be accessed in one of two ways: • Through the NIH Website http://grants.nih.gov/grants/guide/index.html (recommended) • Through Grants.gov http://grants.gov • Review the solicitation and make note of specific requirements such as; • Funding Caps • Limited Submissions • Allowable Costs • Indirect Cost Recovery • Other Solicitation-specific Requirements

10. Preparing an Application Locating the Application Package through the NIH Website

11. Preparing an ApplicationLocating the Application Package through the NIH Website

12. Preparing an ApplicationLocating the Application Package through the NIH Website

13. Preparing an ApplicationLocating the Application Package through Grants.gov

14. Preparing an ApplicationLocating the Application Package through Grants.gov

15. Preparing an ApplicationLocating the Application Package through Grants.gov Make sure the closing date has not expired!

16. Preparing an Application

17. Preparing an Application • Application Filing Name: We recommend using the PIs name, agency name and deadline date. This makes it easier for OSPRA to identify it when the first validation e-mail is received from Grants.gov. Mandatory Forms • SF 424 R&R: Refer to the OSPRA website (Sponsor ERA) for guidance on completing this form. • R&R Project/Performance Site Location(s) • Enter ‘University of Illinois Urbana-Champaign’ as the organization name. • The primary performance site is normally the UIUC campus. The official site for UIUC is: • 506 S. Wright Street • Urbana, IL 61801-3620 (the entire nine digit ZIP code is now required) • List all additional performance sites.

18. Preparing an Application Mandatory Forms • R&R Other Project Information • Respond to questions 1-5, as applicable • Upload Project Summary/Abstract and Project Narrative making sure to comply with guidelines for size limitations. • Sections 8-11 – Upload attachments as applicable and in accordance with guidelines. • Remember: No spaces or special characters in the file name and the document must be in PDF format. • R&R Senior/Key Personnel Profile: • PD/PI, Senior/Key personnel from all participating institutions and other significant contributors (if desired) should be listed.

19. Preparing an Application Mandatory Forms • R&R Senior/Key Personnel Profile • The credential e.g., agency login field is a required field for anyone who is assigned the role of PD/PI. If it is omitted, the application will be rejected with errors in the NIH Commons. • The project role must be selected from the drop down list for all participants except the PD/PI. • NIH does not recognize the role of co-PI. Other (specify) should be selected and co-investigator typed into the Other Project Role Category field. • A biographical sketch is required for all key personnel.

20. Preparing an Application Mandatory Forms • R&R Senior/Key Personnel Profile • The organization name is required by NIH for all Senior/Key personnel or the application will be rejected with errors in the NIH Commons. • Current and Pending Support is normally not required at the time of proposal submission unless indicated in the FOA. This will be requested during the Just-in-Time process.

21. Preparing an Application Mandatory Forms • PHS 398 Cover Page Supplement • The PI name will be pre-populated. • Indicate whether the PI is a new investigator • Complete other sections as applicable. • A portion of the Applicant Organization Contact section is pre-populated and the remainder should be populated as follows: • Title: Director, OSPRA • Street 1: 1901 S. First Street, Suite A • City: Champaign • State: IL • ZIP: 61820-7406

22. Preparing an Application Mandatory Forms • PHS 398 Research Plan • Research Plan Attachments • The Research Plan has been restructured and page limitations have changed effective for due dates on or after January 25, 2010. • Introduction to Application (resubmission/revision only) limited to one page • Specific Aims – one page • Research Strategy – 6-12 page limit depending on funding mechanism • Includes Background and Significance, Preliminary Studies and Research Design and Methods

23. Preparing an Application Mandatory Forms • PHS 398 Research Plan (cont’d) • NIH and OSPRA recommend that the Research Strategy be constructed as a single Word document to ensure that page limitations are not exceeded and then separated into sections and converted to distinct PDF attachments before uploading. • Upload other required documents in accordance with solicitation and mechanism guidelines. • PHS 398 Checklist • Complete as applicable.

24. Preparing an Application Optional Documents • PHS 398 Cover Letter • This is normally optional, but applicants are encouraged to include it. • It is required when submitting a Changed/Corrected application. • PHS 398 Modular Budget • This budget format is required by some programs. Refer to the specific funding opportunity. • Research and Related Budget • When a detailed budget is required by the program. • R&R Subaward Budget Attachment(s) form • Must be completed when a detailed budget is required and project includes a subaward.

25. Completing the Budget Component Refer to the program-specific guidelines to determine the appropriate budget component Modular Budget Guidelines • Applicable to certain grant applications requesting $250K per year in direct costs. • Consortium (subaward) F&A costs are not factored into the direct cost limit. Consortium F&A may be requested in addition to the $250K limit. • Modular budgets are simple, therefore, detailed categorical information is not to be submitted with the application. OSPRA does not require detailed budgets with modular applications. In fact, detailed budgets are not reviewed when they are provided with modular applications. • The modular budget is applicable to R01, R03, R15, R21 and R34 applications.

26. Completing the Budget Component Modular Budget Component • Total direct costs that reflect appropriate support for the project in modules of $25,000 should be requested. • A typical modular grant application will request the same number of modules each year. • Section A – Direct Costs • Direct Costs less consortium F&A. • Consortium F&A, if applicable. • Total Direct Costs automatically calculates. • Section B - Indirect Costs • Indirect Cost type is typically MTDC. • Cognizant Agency – ONR, Linda Shipp, 703-696-8559 • Indirect Cost rate agreement date – 2/20/08 • Budget justification is attached on the cumulative budget page.

27. Completing the Budget Component R&R Budget Component • Should be used if specified in the guidelines. • A separate detailed budget must be prepared for each year of support requested. • The form will generate a cumulative budget for the total project period. • All of the required fields must be completed (i.e., those fields that are highlighted and noted with a “*”). If no funds are being requested for a required field, enter “0”. • Round to the nearest whole number. • Effort should be represented in person months. Resources to calculate this are located at http://grants.nih.gov/grants/policy/person_months_faqs.htm

28. Completing the Budget Component R&R Budget Component –Direct Costs A. Senior/Key Person – allows eight as separate named individuals • All mandatory (yellow) fields must be completed. • The base salary may be left blank, if desired. • Effort must be included and should be represented in person months. B. Other Personnel • Postdocs, Grad Students and Undergrads: Only the number of personnel is required. Provide more detail in the budget justification. • Consultants should not be included in this section. C. Equipment • Equipment is defined as an item of property that has an acquisition cost of $5,000 or more. • Each item of equipment should be listed separately and justified in the budget justification. • General purpose equipment is generally not allowable. D. Travel • Domestic travel includes travel to Canada, Mexico and US possessions.

29. Completing the Budget Component R&R Budget Component-Direct Costs E. Participant/Trainee Support Costs • Unless otherwise stated in the announcement, this section should be left blank. Graduate student tuition remission should be included in section F, Other Direct Costs. F. Other Direct Costs • Material and Supplies • Categories less than $1,000 do not have to be itemized. • Publication Costs • Consultant Services • The names and organizational affiliations of all consultants, along with a description of the services to be performed should be provided.

30. Completing the Budget Component R&R Budget Component-Direct Costs • ADP/Computer Services • Subawards/Consortium/Contractual Costs • Include both direct and indirect costs for all subaward/consortium organizations. • Equipment or Facility Rental/User Fees • Alterations and Renovations 8-10. Use lines 8-10 for costs such as patient care, tuition remission, human subjects, etc. Limit of three other costs. H. Indirect Costs • Indirect cost type – typically MTDC • Cognizant Federal Agency – Office of Naval Research, Linda Shipp, 703-696-8559

31. Completing the Budget Component R&R Subaward Budget Component • A subaward budget component is only required by NIH when a detailed budget is required; however, • OSPRA still requires a SOW, letter of institutional authorization, and a detailed subaward budget for internal purposes. • The budget may be completed by the subawardee or the UIUC PI/department. Regardless of who completes the budget, it should be prepared in much the same manner as the budget is prepared for the lead institution (UIUC). A compatible version of Adobe must be used.

32. Completing the Budget Component R&R Subaward Budget Component • The name of the organization and the DUNS # are required fields. • The subaward/consortium box should be checked. • All mandatory (yellow) fields and other NIH-mandated fields must be completed. • Effort should be represented in person months. • The project role for the investigator who is leading the project at the consortium site should not be assigned the role of PD/PI unless the entire application is being submitted under the Multiple PI policy. • NIH does not recognize the role of co-PI. If desired, the role of ‘Other - Co-Investigator’ may be used. • The file must be a PDF document.

33. Completing the Budget Component R&R Subaward Budget Component • If the budget is being completed by the subawardee organization, • Extract and save the budget attachment using the first 10 letters of the subawardee organization’s name as the file name. • E-mail the saved document to the subawardee. Stress the criticality of using a compatible version of Adobe. • Advise the subawardee to return the completed budget component. • Review the budget to ensure compliance. • Attach the budget to one of the blocks provided on the form.

34. Completing the Budget Component R&R Subaward Budget Component • What if the subawardee’s budgets are not active for all periods of the prime grant? • Limitations in existing forms do not allow an “empty” budget period and do not allow submission of a subaward budget with zero effort to skip a budget period. For example: • Suppose a prime has filled out a budget form with the following periods: • Period 1: 1/1/11-12/31/11 • Period 2: 1/1/12-12/31/12 • Period 3: 1/1/13-12/31/13 • Period 4: 1/1/14-12/31/14 • Period 5: 1/1/15-12/31/15

35. Completing the Budget Component R&R Subaward Budget Component • Suppose a subawardee performs support in year 1 and does not become active again until year 4. The subawardee would fill out the first two periods of their budget form as follows: • Period 1: 1/1/11-12/31/11 (dates correspond to prime period 1) • Period 2: 1/1/14-12/31/14 (dates correspond to prime period 4) If the subaward budget is not prepared in this manner, the application will be rejected with errors during the validation check in the NIH Commons!

36. Submitting the Application REMEMBER: THE FINAL VERSION OF THE PROPOSAL NEEDS TO BE PROVIDED TO OSPRA AT LEAST FIVE DAYS IN ADVANCE OF THE DEADLINE • When the application is complete and ready to be submitted, • Click on “Check Package for Errors” on the first page of the application to ensure that all of the mandatory fields have been completed. Correct any errors that are identified. • Upload the application into Netfiles using the process described on the OSPRA website. • Send the transmittal form via the OSPRA portal (http://www.ospra.uiuc.edu/ “Contact OSPRA”) or fax the proposal transmittal form to 239-6830. • You are no longer required to provide the original proposal transmittal form to OSPRA, but it should be retained by your unit for auditing purposes.

37. Submitting the Application • Upon receipt of the transmittal form, the proposal will be assigned to an OSPRA proposal coordinator. • The coordinator will be in contact during the course of the review for clarification and/or revisions. • When the review is completed, the application will be submitted to Grants.gov by the proposal coordinator.

38. Post Submission • Once the application has been submitted, Grants.gov will send a series of e-mail messages to the proposal coordinator who submitted the application to provide status information. • Submission Receipt: An email is sent indicating the application has been received by Grants.gov and is currently being validated. This e-mail is forwarded to the PI and departmental business contact by the OSPRA proposal coordinator. In this e-mail there will be a link that will allow you to track the status of your proposal. If your proposal does not appear, check back again later.

39. Post Submission Your application has been received by Grants.gov, and is currently being validated. Your submission was received at 16-Jan-10 02:11:51 PM ET Validation may take up to 2 business days.To check the status of your application please click here https://apply07.grants.gov/apply/checkSingleApplStatus.faces?tracking_num=GRANT10506799 Type: GRANT Grants.gov Tracking Number: GRANT10506799 We will notify you via email when your application has been validated by Grants.gov and is ready for the Grantor agency to retrieve and review. DUNS Number: 0415440810000 AOR name: Penny Weaver Application Name: Verify CCR Update_011610 Opportunity Number: PA-10-067 Opportunity Name: Research Project Grant (Parent R01) https://apply07.grants.gov/apply/logincontrol.jsp?goto=./secured/ApplicantLogin.jsp&loginpage=/jsp/ApplicantLoginGetID.jsp

40. Post-Submission Three more e-mails should follow. • Submission Validation Receipt: An email is sent indicating the application has been received and validated by Grants.gov and is being prepared for Grantor agency retrieval. • Grantor Agency Retrieval Receipt: An email is sent indicating the application has been retrieved by the Grantor agency. This e-mail is forwarded to the PI and departmental business contact by the OSPRA proposal coordinator. • Agency Tracking Number Assignment for Application: An email is sent indicating the application has been assigned an Agency Tracking Number.

41. Post-Submission • NIH Commons Validation Process • After the third e-mail is sent by Grants.gov, the application will be downloaded into the NIH Commons for agency validation. • Once agency validation is completed, an agency (not Grants.gov) notification will be e-mailed to the PD/PI and OSPRA. This e-mail will indicate whether any errors or warnings resulted during the validation process. The PD/PI and AOR/SO will be invited to log into the NIH Commons to view the application and/or view the warnings/errors. • Due to the unreliability of e-mail, the PD/PI is encouraged to periodically check on the application status in the NIH Commons. • It is highly recommended that the PI view the assembled application within two business days of submission to ensure that the image is acceptable. • Both NIH and OSPRA recommend against resubmitting an application that contains only warnings.

42. Post-Submission • PI Process for Checking Submission Status and Viewing Application Image • Login to eRA Commons • Select the Status tab • Click on Recent/Pending eSubmissions • Click on Search

43. Post-Submission • Result(s) related to the application will be returned.

44. Post-Submission • The Application Status column will indicate the application status: • ‘e-Submission Error’ means that the validation process revealed errors that require correction and resubmission of the application. • To view a list of the errors, click on the applicable ‘Application ID’. • Keep in mind that only errors are show-stoppers – it is not necessary to correct warnings, in fact NIH and OSPRA advise against doing so.

45. Post-Submission • ‘Received’ means that the application passed the validation check without errors. • If no eRA system errors are identified, the eRA system will: • Assemble the application image • Generate a Table of Contents • Include headers (PI name) and footers (page numbers) on all pages • To view the application and image of the application if no errors are present, click on ‘Verify e-Application’. • No action is required if the image is acceptable. • If the image is unacceptable, contact the OSPRA coordinator who submitted the application.

46. Post-Submission • Frequently encountered errors • Invalid or missing eRA Commons username - entered on the Senior/Key Person Profile component. • Missing organization name for senior/key person - entered on the Senior/Key Person Profile component. • PDF issues • attachments not uploaded in PDF format. • Incompatible version of Adobe used. • Senior/Key person effort on SF424 R&R budget form appears as zero – the effort must be greater than zero for all Senior/Key persons listed. • Federal Identifier is entered in the incorrect format. • Is normally blank for new applications. • Either the Grants.gov tracking number or N/A is required for Changed/Corrected applications. • For Renewals, Resubmissions, or Revisions, the IC (Institute/Center) and serial number of the prior application/award must be entered in a particular format (e.g., for application #3R01CA123456 the Federal Identifier would be CA123456).

47. Post-Submission • Submitting a Corrected Application • Contact the coordinator who submitted the application. • Correct the errors. • On the SF424 in box 1, check “Changed/Corrected”. • Once the Changed/Corrected box is checked, the Federal Identifier field (box 4) becomes a required field for a new application. Enter the Grants.gov tracking number (or N/A if it is not known). • If the submission deadline has passed, a cover letter must be included explaining the changes and why the application is late. If a cover letter was included previously, that information should also be included as it is not retained. • The revised version of the application should be delivered to OSPRA via Netfiles. • The entire Changed/Corrected application must be submitted through Grants.gov by OSPRA. • This process is intended to be used to correct errors only and not to make significant changes to the application.

48. Remember… • OSPRA needs to be provided the application at least five business days before the deadline. • The entire proposal should be in its FINAL state when it is provided to OSPRA. • No Grants.gov registration is required on the part of the PI. • The PD/PI must have a Commons ID in order to successfully submit an application. This should be obtained through OSPRA at least two weeks in advance of submission. Instructions for requesting a Commons ID may be found on the OSPRA website http://www.ospra.uiuc.edu/ • The program-specific guidelines should be obtained and carefully reviewed as soon as possible in advance of the deadline. • All attachments must be in PDF format. • A compatible version of Adobe must be used. • Both NIH and OSPRA advise against resubmitting an application that contains warnings only (no errors).

49. Reference Materials • OSPRA Website http://www.ospra.uiuc.edu/ • Checklist for Expedited Review of NIH Applications http://www.ospra.uiuc.edu/forms/Checklist%20for%20Expedited%20Review%20of%20NIH%20Proposals%20121608.doc • NIH Electronic Submission of Grant Applications http://era.nih.gov/ElectronicReceipt/index.htm • NIH Grants.gov Application Guide http://grants.nih.gov/grants/funding/424/sf424_rr_guide_general_ver2.doc • NIH Commons https://commons.era.nih.gov/commons/ • NIH Grants.gov Transition Timeline http://era.nih.gov/ElectronicReceipt/files/electronic_submission_timeline_08.pdf

50. Contact Information James Wade, Assistant Director, OSPRA 244-8212, jwade1@illinois.edu Penny Weaver, Assistant Director, OSPRA 265-7679, pkweaver@illinois.edu NIH Commons Help Desk (866)504-9552, commons@od.nih.gov Grants.gov (800)518-4726