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

2. SF424 (R&R) Cover Component Page 2

3. 3 Component: SF424 (R&R) – A Cover Component Similar to the PHS 398 Face Page Provides general information about the applicant organization, contact information for the PD/PI and AOR/SO Provides application-specific information (type, title etc.)

4. 4 SF424 (R&R) - A Cover Component: A Few Data Issues Item 1, Type of Submission –Pre-application - do not use unless specifically noted in FOA –Changed/Corrected Application—To be used only when correcting an application that failed system validations. This is NOT a resubmission (amendment). Item 5, Applicant Information: This is for the applicant organization

5. 5 SF424 (R&R) - A Cover Component: A Few Data Issues Item 5, Organizational DUNS: Must match DUNS in eRA Commons profile for Applicant Institution –AOR should verify DUNS in Commons profile before submission –Use Organizational DUNS (not any DUNS for a specific individual) –If Organization has multiple DUNS, pick a single one for NIH grants

6. 6 SF424 (R&R) - A Cover Component: A Few Data Issues Item 8, Type of Application--New Terminology –New is the same –Resubmission is equivalent to a Revision (a revised or amended application) –Renewal is equivalent to a Competing Continuation –Continuation is equivalent to a Progress Report. For the purposes of NIH and other PHS agencies, the box for Continuation will not be used and should not be checked. –Revision is somewhat equivalent to a Competing Supplement Terminology crosswalk provided in instructions

7. 7 SF424 (R&R) - A Cover Component: A Few Data Issues Item 10, CFDA Number & Title –CFDA = Catalog of Federal Domestic Assistance –Fields are pre-filled based on the specific announcement –Fields may be blank for applications in response to an FOA that includes multiple CFDAs –When multiple CFDAs are listed in an announcement, a CFDA will be assigned by the eRA system once a specific Institute assignment is made

8. Project/Performance Site Locations

9. 9 R&R Project/Performance Site Locations Equivalent to the PHS 398 Form Page 2 Performance Site section Collects individual data for up to 8 locations >8 locations – information is provided in an attachment (not structured data, just text) Format for the >8 attachment available on SF424 (R&R) Forms Page: http://grants.nih.gov/grants/funding/424/index.htm http://grants.nih.gov/grants/funding/424/index.htm

10. Other Project Information

11. 11 R&R Other Project Information Includes information on involvement of Human Subjects, Vertebrate Animals, Environmental Impact, Foreign Involvement Includes separate PDF attachments for –Project Summary/Abstract (Description) –Project Narrative NIH will use this upload for the “Relevance” section of the Abstract Separate component developed for Research Plan –Bibliography & References (previously section G. Literature cited) –Facilities & Other Resources –Equipment Resources

12. Senior/Key Person Profile

13. 13 R&R Senior/Key Person Version 1 & 2 Captures personal profile information on the PD/PI, Key Personnel, and Other Significant Contributors Captures structured data for 8 individuals (PI and 7 others) >8 information is provided in an attachment (not structured data, just text) Format for the >8 attachment available on SF424 (R&R) Forms Page: http://grants.nih.gov/grants/funding/424/index.htm http://grants.nih.gov/grants/funding/424/index.htm

14. Senior/Key Person Profile (Expanded)

15. 15 Research & Related Senior/Key Person (Expanded) Version 2A This is the only change in the forms for packages noted as Version 2A. Captures structured data for up to 40 Senior/Key Persons.

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

17. 17 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 that allows up to four additional Senior/Key Person (PureEdge) components to be attached (each containing another 8 individuals).

18. 18 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.

19. 19 R&R Senior/Key Person & Sr./Key Expanded Credential: Must enter the eRA Commons User Name - for the PD/PI, this is a mandatory field for NIH submissions. (Most common validation failure to date) Biosketch is attached for each person –Same data requirements exist; however, page limits slightly change to just 4 pages –Eliminated the 2-page limit for subsections

20. 20 R&R Senior/Key Person & Sr./Key Expanded Attachment for Current & Pending Support (a.k.a. Other Support) is not required at submission unless specified in FOA. For most applications, this will continue to be a Just-In-Time submission

21. R&R Budget Sections A & B

22. 22 R&R Budget, Sections A & B Personnel separated into 2 sections A. Senior/Key Person –Allows 8 as named individuals & structured data –> 8 information is provided in an attachment (not structured data, just text) –Info for PD/PI must be entered, even if $ = 0 B. Other Personnel –Postdocs, Grad Students, Undergrads: captures # only –NIH will request more detail in Budget Justification

23. 23 R&R Budget, Sections A & B Change from Percent Effort to Person Months –Must enter either Calendar, Academic and/or Summer for all Senior/Key Persons –Incorporated this business process change throughout--See 4/2006 Interim change to PHS 398 & PHS 2590 Progress Report, including Budget Pages, Other Support documentation, Key Personnel Reports, etc. –FAQs and Calculator available at: http://grants.nih.gov/grants/policy/person_months_faqs.htm http://grants.nih.gov/grants/policy/person_months_faqs.htm

24. R&R Budget Sections C - E

25. 25 R&R Budget, Sections C - D C. Equipment –Allows itemization of up to 10 –>10 equipment items: details provided in an attachment – total funds requested in attachment are entered in Line 11 D. Travel –R&R separates out Domestic & Foreign –This will not change any NIH policy/practice. We will continue to award as a single category.

26. 26 R&R Budget, Section E E. Participant/Trainee Support Costs –Will not be used by NIH unless specifically noted in an announcement –Tuition Remission will continue to be included in Section F Other Direct Costs

27. R&R Budget Sections F - K

28. 28 R&R Budget, Sections F - I F. Other Direct Costs –Itemizes: Supplies, Publication Costs, Consultants, ADP/Computer Services, Consortium Costs, Equipment or Facility Rental/User Fees, Alterations & Renovations –Have included agency-specific instructions to use this section to also account for patient care costs & tuition remission G. Total Direct Costs (A – F) H. Indirect Costs I. Total Costs (G+H)

29. 29 R&R Budget, Sections J - K J. Fee K. Budget Justification – a PDF text attachment Next Period Button: At the top of the last budget page. All required data fields in this component must be entered before this button is available. This includes the Budget Justification.

30. 30 R&R Budget, General Notes Applicant prepares a detailed budget for every budget period There is no summary budget page like the PHS 398 Form Page 5 A detailed Cumulative budget is system- generated

32. 32 R&R Subaward Budget Attachment Form Use for detailed budget from any consortium grantee only when the prime is submitting detailed budget Do not use if prime is submitting Modular Budget Consortium grantee(s) must have PureEdge installed

33. 33 R&R Subaward Budget Attachment Form Allows up to 10 separate budget attachments— one for each consortium grantee Applicant sends the R&R budget component to the consortium grantee for completion; it is returned to the applicant; applicant attaches it in this component Applicant still needs to include the total costs for all consortiums in their own detailed budget, Section F.5

34. SBIR/STTR Information Page 1

35. SBIR/STTR Information Page 2

36. 36 SBIR/STTR Information Includes eligibility questions answered by both SBIR & STTR applicants as well as separate sections for SBIR & STTR- specific questions Includes Commercialization Plan as PDF Attachment

37. 37 Agency-specific Components (a.k.a. PHS 398 Components) PHS 398 Cover Letter File PHS 398 Cover Page Supplement (supplements the R&R Cover) PHS 398 Modular Budget PHS 398 Research Plan PHS 398 Checklist

39. 39 PHS 398 Cover Letter Provides a text attachment for a cover letter Instructions to applicant remain the same as in the PHS 398 Is stored separately in the eRA Grant Folder, not as a part of the main application grant image

40. 40 PHS 398 Cover Letter Is seen only by appropriate NIH staff; not peer reviewers Required when submitting a Changed/Corrected Application after submission date If revising the cover letter for a Changed/Corrected application, include all previously submitted letter text

41. PHS 398 Cover Page Supplement Page 1

42. PHS 398 Cover Page Supplement Page 2

43. 43 PHS 398 Cover Page Supplement Companion form to the (R&R) Cover Component For the PI, includes New Investigator Code & Degree fields (Note, PD/PI info at the top is pre-filled. Provided here for reference only.) Includes Clinical Trial & Phase-III defined clinical trial indicators

44. 44 PHS 398 Cover Page Supplement For the Business Official Contact, includes complete contact information (title & mailing address missing from section 5 of the R&R Cover) Includes Human Embryonic Stem Cells section

45. PHS 398 Modular Budget

46. 46 PHS 398 Modular Budget Provides data entry for each budget period –A. Direct Costs DC less consortium F&A Consortium F&A Total DC –B. Indirect Costs Calculation section –C. Total Costs (A + B) Cumulative Budget is system-generated Budget Justification: PDF text attachments for Personnel, Consortium and Other

47. PHS 398 Research Plan

48. 48 PHS 398 Research Plan Separate PDF attachments for each section (designed to maximize benefits of system validations & to accommodate bookmarking of the image) Same formatting requirements in the PHS 398 continue here – margins, page limits, etc.

49. 49 PHS 398 Research Plan Appendix Material –Allows up to 10 separate attachments –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 –See recent changes in Appendix Material, Guide Notice NOT-OD-07-018: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html

50. 50 PHS 398 Research Plan Helpful Hints Create as a single document using any word processing software. Separate at the end before uploading. Do not include headers or footers Include a section heading as part of the text (i.e., Specific Aims, Background & Significance) Avoid 2-column format for text (difficult for reviewers to read electronically)

51. PHS 398 Checklist Page 1

52. PHS 398 Checklist Page 2

53. 53 PHS 398 Checklist Captures additional information currently in the PHS 398 Checklist –Change of PI –Change of Grantee Institution –Inventions & Patents –Program Income –PDF text upload for an Assurances/Certifications explanation

54. Application Complete… Next Steps Megan Columbus

55. 55 Be sure all Mandatory Documents are completed and moved to the submission list. Refer to the agency-specific instructions for which Optional Documents are required. Be sure to “Save” the completed application package to your local hard drive.

56. 56 The Check Package for Errors button will ONLY show Grants.gov errors. You must Submit the application for it to go through the NIH validation process. NIH errors will be shown in the eRA Commons.

57. 57 The AOR submits the application to Grants.gov. Registration with Grants.gov and eRA Commons must be complete to successfully submit.

58. 58 The AOR Signs & Submits Only the AOR may sign and submit the application on behalf of the organization.

59. 59 AOR Submits

60. 60 Submit Application Scroll to the bottom of the Grants.gov confirmation screen to receive your Tracking Number and Date/Time Stamp. Applications are due 5 p.m. local time of the applicant org. on day of submission deadline.

61. 61 Expected Turnaround Times Grants.gov response to an application submission – generally within hours, up to 2 weekdays eRA Commons response to an application submission – generally within hours, up to 1 weekday AOR/SO and PI review of application image – within 2 weekdays of availability in eRA Commons

62. 62 Grants.gov Validations All Grants.gov mandatory fields have been completed All mandatory documents have been completed and moved to the Completed Documents box (Submission List) Checks the DUNS # Checks date format, email address format, and scans for viruses

63. 63 Email Notifications – Grants.gov AOR receives emails Submission Receipt – app received and is being validated Rejection Notice – app is not validated because of Grants.gov errors Submission Validation Receipt – app has been validated Grantor Agency Retrieval Receipt – app has been retrieved by the agency Agency Tracking Number – app has been assigned a tracking number by the grantor agency

64. 64 Check Status in eRA Commons After submission, the eRA Commons system will: –Apply the NIH validations –Assemble the grant image –Generate a Table of Contents –Include headers (PI name) & footers (page numbers) on all pages

65. 65 eRA Commons Validations The eRA Commons checks the application against NIH business rules –Detailed check against the instructions in the application guide –Validates against the instructions in the specific FOA –For a detailed list of NIH validations: http://era.nih.gov/ElectronicReceipt/prepare_app.htm#5 http://era.nih.gov/ElectronicReceipt/prepare_app.htm#5

66. 66 Email Notifications - eRA Commons AOR/SO and PI receive emails Validations Complete/Check Assembled Application Validations Complete/Check Assembled Application – Warnings Only Action Required: Errors and/or Warnings, Missing or Invalid Commons Username, System Error SO has refused application – SO rejected the application

67. 67 Check Status in Commons – PD/PI 1. Click the Status tab to view the PI Status. 2. Find application that shows “eSubmission Error” in the Application Status column. 3. Follow the link on the Application ID to see specific Error/Warning messages.

68. 68 View Errors/Warnings

69. 69 Errors & Warnings Errors must be addressed before the application can move on to Referral. Warnings may be fixed at the applicant’s discretion but do not require action for the application to move on. If the PI corrects any Warnings or Errors, they should contact the AOR/SO. The AOR/SO must submit the entire changed/corrected application again through Grants.gov.

70. 70 Check Status in Commons AOR/SO Search screen allows the AOR/SO to narrow the list of results. Click Show Prior eSubmission Errors to view application errors.

71. 71 Check Assembled Application View the Application Image by clicking on the Application ID

72. 72 Check Assembled Application Next, click on the e-Application link to view the image.

73. 73 Application Image Be sure to review the entire application carefully! Your application is not considered received by NIH until you see the application image in the eRA Commons.

74. 74 Check Assembled Application The AOR/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.

75. 75 Application Complete!

76. Resources for Assistance

77. Electronic Submission Information: http://era.nih.gov/ElectronicReceipt/

78. 78 Resources Sample Document: “eRA Assembly of the SF424 (R&R) Application” –Includes a sample Table of Contents, and; –a chart cross-referencing the location in the forms components for each piece of the grant image. http://grants.nih.gov/grants/funding/424/index.htm

79. Application Guide(s), Sample Application Packages, Additional Format Pages found at: http://grants.nih.gov/grants/funding/424/index.htm http://grants.nih.gov/grants/funding/424/index.htm

80. 80 Training Tools Registration eRA Commons Registration – Automated Training Demo http://era.nih.gov/virtualschool/external/c101_GranteeRegistrationPr ocess.htm http://era.nih.gov/virtualschool/external/c101_GranteeRegistrationPr ocess.htm Working with the Application Form A “Walk Through the SF424 (R&R)” - Video http://helix.od.nih.gov/oervideo/grantsgov/A_Walk_Through_SF424/i ndex.html “Completing an Application Package” – Grants.gov Automated Demo http://www.grants.gov/images/Application_Package.swf

81. 81 Training Tools Learning the Electronic Submission Process Interacting Electronically with NIH –Part I & II – Videos Hands-On Learning Creating a Commons Demo Account – Learn the system and get familiar with the forms BEFORE you submit! –Check the status of sample applications in various stages of submission –View errors & warnings –See application images Videos/Hands-On: http://era.nih.gov/ElectronicReceipt/training.htmhttp://era.nih.gov/ElectronicReceipt/training.htm

82. 82 Training Tools Presentations Archive of this training session will be available in streaming video and downloadable formats: http://era.nih.gov/ElectronicReceipt/training.htm http://era.nih.gov/ElectronicReceipt/training.htm Review the Application Guides & Sample Application Packages SF424 (R&R) application guides, sample application packages and related resources http://grants.nih.gov/grants/funding/424/index.htm http://grants.nih.gov/grants/funding/424/index.htm

83. 83 Training Tools Registration in the eRA Commons (Demo) http://era.nih.gov/virtualschool/external/c101_GranteeRegistrationPr ocess.htm http://era.nih.gov/virtualschool/external/c101_GranteeRegistrationPr ocess.htm Grants.gov’s “How to Complete An Application Package” Demo SF424 (R&R) application guides, sample application packages and related resources http://grants.nih.gov/grants/funding/424/index.htm http://grants.nih.gov/grants/funding/424/index.htm

84. 84 Other Tools Frequently Asked Questions http://era.nih.gov/ElectronicReceipt/faq.htm http://era.nih.gov/ElectronicReceipt/faq.htm Electronic Submission Transition Timeline http://era.nih.gov/ElectronicReceipt/strategy_timeline.htm http://era.nih.gov/ElectronicReceipt/strategy_timeline.htm Avoiding Common Errors http://era.nih.gov/ElectronicReceipt/avoiding_errors.htm http://era.nih.gov/ElectronicReceipt/avoiding_errors.htm Communications and Outreach Resources (brochures, presentations, drop-in newsletter articles) http://era.nih.gov/ElectronicReceipt/communication.htm http://era.nih.gov/ElectronicReceipt/communication.htm

85. 85 Finding Help: Grants.gov If help is needed with the Grants.gov registration process or with technical aspects of submitting through the Grants.gov system or PureEdge: –Check the resources available on the Grants.gov website (http://grants.gov/ )http://grants.gov/ –Grants.gov help is also provided by the following office: Grants.gov Customer Support Contact Center Phone: 1-800-518-4726 Business Hours M-F 7 a.m.- 9 p.m. EST Email support@grants.govsupport@grants.gov Registration & Submission

86. 86 Finding Help: eRA Commons If help is needed with eRA Commons registration or validations after submission through Grants.gov: –Check the eRA Commons website: https://commons.era.nih.gov/commons/index.jsp –eRA Commons Help Desk Phone: 301-402-7469 Toll Free: 866-504-9552 TTY: 301-451-5939 Business hours M-F, 7am-8pm EST Web support: http://ithelpdesk.nih.gov/eRA/http://ithelpdesk.nih.gov/eRA/ Use the web support! Enter your own help ticket! Registration & Validations Processes

87. 87 Finding Help: Application Preparation Review the Application Instruction Guide(s) Contact Grants Info: Grants Info Phone: 301-435-0714 TTY: 301-451-0088 Email GrantsInfo@nih.govGrantsInfo@nih.gov

88. 88 Finding Help All of these resources and forms are found on the Electronic Submission website at: http://era.nih.gov/ElectronicReceipt/

89. Lessons Learned NIH Panel of Experts

90. 90 NIH Electronic Submission Panel of Experts Megan Columbus, NIH Program Manager for Electronic Submission of Grant Applications Suzanne Fisher, Director, Division of Receipt and Referral, Center for Scientific Review Jennifer Flach, eSubmission Technical Development Manager Scarlett Gibb, Manager, eRA Help Desk Marcia Hahn, Director, Division of Grants Policy, Office of Policy for Extramural Research Administration

91. 91 Lessons Learned Work with your Office of Sponsored Research to determine your internal process flow (review, approval, document sharing etc.) Register now to be prepared –All PIs and Fellows need to be registered –Can take 2 – 4 weeks; up to 8 weeks for newly established organizations Read and follow all instructions in the FOA & the application package instructions!

92. 92 Lessons Learned All non-PureEdge attachments MUST be in PDF format DO NOT: Use special characters in file names Write-protect the PDF file; you should disable all security features in the PDF Scan text attachments. Generate using word processing package and then convert to PDF. For more information: http://era.nih.gov/ElectronicReceipt/faq_prepare_app.htm#2e

93. 93 Lessons Learned Organizational DUNS in the application must match DUNS in the eRA Commons profile for the Applicant Institution The “credential e.g., agency login” field on the R&R Senior/Key Person Profile component MUST contain the PI’s eRA Commons User ID for NIH to process the application submission

94. 94 Lessons Learned When submitting a Changed/Corrected application, make sure you check the “Changed/Corrected” box in Field #1 Type of Submission Allow extra time for corrections

95. 95 Lessons Learned Take time to closely review the grant image within 2 weekdays of availability –Ensure ALL PDFs are attached –Check each one for proper conversion & formatting New Process…but It’s Still About the Science! Our philosophy and policy has not changed!

96. Q&A with the NIH Panel of Experts

97. 97 How To Submit Questions Live Audience –Index cards in your folder –One question per card please! Videocast Audience –Submit questions online using the Live Event Feedback Form or; –Send an email to the NIH Electronic Submission mailbox NIHElectronicSubmiss@mail.nih.gov

98. 98 Collecting User Feedback NIH has established an email address to collect comments and/or suggestions from users: NIHElectronicSubmiss@mail.nih.gov Share specific suggestions for improvement Share what resources are most useful (Targeted Emails, FAQs, Avoiding Common Errors, Commons Alerts, Training Tools etc.)

99. Thank You!