NIH Electronic Grant Submission. Maqsood Wani

Transcription

1 NIH Electronic Grant Submission Maqsood Wani

2 Electronic Submission Process New Process New Forms but It s Still About the Science! Our philosophy and policy has not changed! 2

3 The Plan OMB set the following FY 2007 goal for agencies: Post 100% of funding opportunities on Grants.gov Apply. By the end of Sept. 2007, NIH plans to: Require electronic submission through Grants.gov for all NIH grant applications Transition from the PHS 398 application form to the SF424 (R&R) 3

4 Successful Transitions SBIR/STTR (Dec. 1, 2005) R13/U13 (Dec. 15, 2005) R36 (Feb. 17, 2006) R15 (Feb. 25, 2006) S10 (Mar. 22, 2006) X02 (April 18, 2006) X01 (May 18, 2006) R03, R21, R21/R33, R34 (June 1, 2006) R18/U18, R25, C06/UC6 (Oct. 1, 2006) R01 Multi-PI Pilot

5 Transitioning in 2007 DP1 (Jan. 16) R01 (Feb. 5) Resource (G7, G8, G11, G13, G20), S11, S21, S22 (May 25) Career Development (all Ks except K12) (Jun. 12) Fellowship (F) (Aug. 8) Training (T&D), U45, D71/U2R, Project/Center (P), G12, M01, R10/U10, S06, SC1, SC2, SC3, R24/U24, U01, U19, U54, U56 (Sept. 25) K12 (Oct.12)

6 Electronic Submission Process Prepare to Apply Find Opportunity and Download Application Package Prepare Application Submit Application to Grants.gov (AOR submits) Check Submission Status in Commons Check Assembled Application Submission Complete 6

7 Two Systems Working Together Grants.gov Federal government s single online portal to find and apply for Federal grant funding Used by all 26 Federal grant-making agencies 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 7

8 Prepare to Apply Registration 8

9 Prepare to Apply Registration Grants.gov Applicant Organization only (one time) Obtain EIN from IRS Request DUNS from Dun & Bradstreet Register with CCR identify the ebiz Point of Contact (POC) Register the Authorized Organization Reps (AORs) who can officially submit on behalf of your organization Can take 2 4 weeks; up to 8 for newly established businesses 9

10 Prepare to Apply Registration era Commons - Organization Register your organization/institution (one time) Register your Signing Official (SO) Register and create a separate account for your Project Director/Principal Investigator Registration may be completed simultaneously with the Grants.gov registration (as soon as the DUNS # is obtained) Allow 2 4 weeks to complete 10

11 Prepare to Apply Registration era Commons PD/PI Principal Investigators (PIs) must work through their institutions to register. The PI and Signing Official (SO) need separate accounts in era Commons because each has different privileges. PIs have one account that follows them throughout their careers the same account may be affiliated with multiple organizations. Allow 4-5 business days to complete. 11

12 Software Prepare to Apply PureEdge Viewer free at Grants.gov: #pureedge PDF generation software list provided on Grants.gov website 12

13 Find Opportunity & Download Package ALL applications must be submitted in response to a Funding Opportunity Announcement (FOA) NIH will simultaneously post FOAs in the NIH Guide for Grants and Contracts and Grants.gov Find The NIH Guide is located on the Office of Extramural Research Homepage at: 13

14 Office of Extramural Research New Parent FOA page added for quick 14 reference to unsolicited applications.

15 Enter search criteria or Select Advanced Search 15

16 Select the FOA number to open the announcement. 16

17 Find Opportunity & Download FOA Within the announcement Click the Apply for Grant Electronically button This will take you directly to Grants.gov so you may download the package 17

18 Download FOA From Grants.gov 18

19 Download Application & Instructions Important Tip: Sign up to receive notification of changes to the FOA! Download the application and instructions from this location. 19

20 Select Save to save the application package to your local hard drive. You will receive a warning message each time you save until all required data is 20 entered.

21 Features of the SF424 (R&R) A complete application to NIH will include a combination of (R&R) components & PHS 398 components. The applicant must complete the application using the package attached to that particular FOA. Information from the specific FOA is used in the forms. 21

22 Features of the SF424 (R&R) Applicants cannot use any sample form packages or form packages from other announcements. The applicant will complete data entry in all necessary components and upload appropriate attachments. 22

23 Features of the SF424 (R&R) SF424 (R&R) Components include: SF424 (R&R) An application cover component Research & Related Project/Performance Site Location (s) Research & Related Other Project Information Research & Related Senior/Key Person (Expanded) Research & Related Budget Research & Related Personal Data (NIH will not use) R&R Subaward Budget Attachment Form SBIR/STTR Information 23

24 Features of the SF424 (R&R) NIH requires additional information for review of its biomedical research portfolio. Therefore, NIH has developed agencyspecific components (titled PHS 398): 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 24

25 Features of the SF424 (R&R) Application components include specific data fields as well as multiple attachments Most attachments are text NIH requires PDF text attachments 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 25

26 Features of the SF424 (R&R): Application Guide NIH has developed 2 Application Guides specific to the SF424 (R&R): 1) General Instructions 2) General +SBIR/STTR Includes instructions embedded in the actual forms as well agency-specific instructions Agency-specific instructions denoted with the HHS Logo 26

27 Prepare Your Application Header Information Pre-filled from Announcement The CFDA Number will be left blank for NIH Opportunities All Mandatory Documents for the FOA will be included in the application package. 27

28 Prepare Click this Your button Application for field-specific help. Grants.gov mandatory fields will have an asterisk and will be highlighted 28

29 Application Complete Next Steps

30 Be sure to Save the completed application package to your local hard drive. 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. 30

31 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. 31

32 The AOR submits the application to Grants.gov. Registration with Grants.gov and era Commons must be 32 complete to successfully submit.

33 The AOR Signs & Submits Only the AOR may sign and submit the application on behalf of the organization. 33

34 AOR Submits 34

35 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. 35

36 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 36

37 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, address format, and scans for viruses 37

38 Notifications Grants.gov AOR receives s 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 38

39 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 39

40 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: 40

41 Notifications - era Commons AOR/SO and PI receive s 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 41

42 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. 42

43 View Errors/Warnings 43

44 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. 44

45 Check Status in Commons AOR/SO earch screen allows the AOR/SO to narrow the list of results. Click how Prior esubmission Errors to view application errors. 45

46 Check Assembled Application View the Application Image by clicking on the Application ID 46

47 Check Assembled Application Next, click on the e-application link to view the image. 47

48 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. 48

49 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. 49

50 Application Complete! 50

51 Process Overview Prepare to Apply Find opportunity and download app. package Register Obtain Software: PureEdge; Citrix-Mac; PDF Generator AOR registers with Grants.gov & Commons PI registers through AOR/SO in era Commons Prepare app. Submit application to Grants.gov (AOR submits) Wait for NIH to retrieve application Check submission status in Commons View assembled app. Submission complete Grants.gov performs basic checks era Commons checks application against guidelines Errors Found Processed successfully; no errors (may have warnings) PI & AOR/SO view app; AOR/SO has option to reject or app. moves forward after 2 weekdays If errors found, AOR must submit corrected application to Grants.gov Application assembled 51

52 Resources for Assistance

53 Electronic Submission Information:

54 Thank You!

55 Prepare to Apply Options for Mac users (using downloadable forms) 1. Download free CITRIX server to remotely launch a Windows session 2. Use PC emulation software 3. Download the IBM Workplace Forms (PureEdge) Viewer for Mac Early release version with significant limitations See the Grants.gov website for detailed info: 55

56 Prepare to Apply Determine your internal review & approval process Determine how you will share applications in progress Decide how to manage the last minute queue at Sponsored Programs (rather than using an airport FedEx drop box!) 56

57 Investigator Initiated Research NIH is committed to investigator-initiated research and we want your unsolicited applications! Since all applications must be submitted in response to an FOA we ve created Parent FOAs Apply using the Parent electronic application package for your chosen mechanism 57

58 NIH Preparation for R01s We expect 4,500-5,000 unique R01 applications in February We have already accepted R01 applications as part of a pilot for multi-pi applications in September We have done extensive risk analysis and capacity planning to ensure readiness Increased resources for Help Desk and staff training 58

59 Features of the SF424 (R&R): Application Package Header Header page is attached to every posted application package Header data is pre-filled from the announcement Notes which components are required (mandatory) and which are optional for the announcement Includes basic instructions Includes Application Submission Verification & Signature screen 59

60 SF424 (R&R) Cover Component Page 1 60

61 SF424 (R&R) Cover Component Page 2 61

62 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.) 62

63 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 63

64 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 64

65 SF424 (R&R) - A Cover Component: A Few Data Issues Item 8, Type of Application--New Terminology Newis the same Resubmissionis 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. Revisionis somewhat equivalent to a Competing Supplement Terminology crosswalk provided in instructions 65

66 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 66

67 Project/Performance Site Locations 67

68 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: 68

69 Other Project Information 69

70 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 70

71 Senior/Key Person Profile 71

72 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: 72

73 Senior/Key Person Profile (Expanded) 73

74 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. 74

75 Senior/Key Person Profile (Expanded) Additional Senior/Key Person Form Attachments 75

76 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). 76

77 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. 77

78 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 78

79 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 79

80 R&R Budget Sections A & B 80

81 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 81

82 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: 82

83 R&R Budget Sections C - E 83

84 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. 84

85 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 85

86 R&R Budget Sections F - K 86

87 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) 87

88 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. 88

89 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 systemgenerated 89

90 90

91 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 91

92 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 92

93 SBIR/STTR Information Page 1 93

94 SBIR/STTR Information Page 2 94

95 SBIR/STTR Information Includes eligibility questions answered by both SBIR & STTR applicants as well as separate sections for SBIR & STTRspecific questions Includes Commercialization Plan as PDF Attachment 95

96 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 96

97 97

98 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 98

99 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 99

100 PHS 398 Cover Page Supplement Page 1 100

101 PHS 398 Cover Page Supplement Page 2 101

102 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 102

103 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 103

104 PHS 398 Modular Budget 104

105 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 105

106 PHS 398 Research Plan 106

107 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. 107

108 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 : 108

109 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) 109

110 PHS 398 Checklist Page 1 110

111 PHS 398 Checklist Page 2 111

112 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 112

113 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

114 Application Guide(s), Sample Application Packages, Additional Format Pages found at: 114

115 Training Tools Registration era Commons Registration Automated Training Demo ocess.htm Working with the Application Form A Walk Through the SF424 (R&R) - Video ndex.html Completing an Application Package Grants.gov Automated Demo 115

116 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: 116

117 Training Tools Registration in the era Commons (Demo) ocess.htm Grants.gov s How to Complete An Application Package Demo SF424 (R&R) application guides, sample application packages and related resources 117

118 Other Tools Frequently Asked Questions Electronic Submission Transition Timeline Avoiding Common Errors Communications and Outreach Resources (brochures, presentations, drop-in newsletter articles) 118

119 Finding Help: Grants.gov Registration & Submission 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 ( ) Grants.gov help is also provided by the following office: Grants.gov Customer Support Contact Center Phone: Business Hours M-F 7 a.m.- 9 p.m. EST support@grants.gov 119

120 Finding Help: era Commons Registration & Validations Processes If help is needed with era Commons registration or validations after submission through Grants.gov: Check the era Commons website: era Commons Help Desk Phone: Toll Free: TTY: Business hours M-F, 7am-8pm EST Web support: Use the web support! Enter your own help ticket! 120

121 Finding Help: Application Preparation Review the Application Instruction Guide(s) Contact Grants Info: Grants Info Phone: TTY:

122 Finding Help All of these resources and forms are found on the Electronic Submission website at: 122