1 Electronic Research Administration Office of Extramural Research National Institutes of Health June 2011 Successful eSubmission of NIH Grant Applications Sheri Cummins eRA Customer Relationship Manager – eSubmission Deven Tines Service Center Representative – Commons & eSubmission

2 Two Separate, but Linked Systems Grants.gov Federal-wide portal to find and apply for Federal grant funding Used by all 26 Federal grant-making agencies eRA Commons Agency system that allows applicants, grantees and Federal staff to share application/grant information Used by NIH and a few other HHS divisions IMPORTANT: Each system has its own registration and application requirements.

3 Electronic Submission of Grant Applications to NIH AOR/SO PI Find and download announcement, instructions and form package. Principal Investigator (PI) prepares application per institution guidelines. PI sends app. to Authorized Organization Rep. (AOR), who submits application to Grants.gov. eRA retrieves application from Grants.gov and checks it for compliance with application instructions. PI and AOR/ Signing Official (SO) check submission status and view assembled application in eRA Commons. PI

4 eSubmission Web Site

5 Prepare to Apply & Register Find Opportunity Prepare Application Submit, Track & View Submission Complete

6 Registration Grants.gov Applicant Organizations only Designate E-Business Point of Contact (E-Biz POC) Approves Authorized Organization Representatives (AORs) providing authority to submit applications No registration needed to find opportunities or download forms eRA Commons Applicant Organization & PD/PI Designate Signing Official (SO) Registers or affiliates Project Director/Principal Investigator (PD/PI) Many organizations are already registered. Check with your Office of Sponsored Projects.

7 Registration Tips for Success: If not yet registered, start the process at least 4 weeks before the deadline Once DUNS number is obtained, Grants.gov and eRA Commons registrations can be done in tandem NIH 2-week “good faith effort” for Commons registration Set-up multiple AOR and SO accounts Log in to accounts prior to deadline to ensure you have access to the systems Update Central Contractor Registration (CCR) information yearly to keep credentials active

8 Registration More Tips for Success: Do not combine SO and PI roles on single Commons account PIs get one Commons account that follows them throughout their careers If PI is already registered, “affiliate” their existing account rather than creating a new one PIs should update their Commons profile prior to submitting (e.g., degree info used to determine Early Stage Investigator eligibility)

9 Obtain Software Adobe Reader Only specific Adobe Reader versions are compatible with Grants.gov forms PDF conversion program Attachments must be converted to PDF Grants.gov download software page

10 Make a Submission Plan Internal organization considerations… Submission method Downloadable forms System-to-system using XML data stream Services of a commercial service provider Application preparation responsibilities Sharing applications in progress Internal review & approval process Internal deadlines Administrators and PIs must work together!

11 Find Opportunity Prepare to Apply & Register Find Opportunity Prepare Application Submit, Track & View Submission Complete

12 Find Opportunity ALL applications must be submitted in response to a specific Funding Opportunity Announcement (FOA) NIH simultaneously posts FOAs in: NIH Guide for Grants and Contracts Grants.gov Find Grant Opportunities Some FOAs focus on specific areas of research and others provide instructions and forms for general grant programs Use “Parent” FOAs for unsolicited applications htm htm

Finding FOAs in Grants.gov Grants.gov For Applicants: Find Grant Opportunities

Finding FOAs in Grants.gov Click Advanced Search or other desired search Enter search criteria and click Search 14

Finding FOAs in Grants.gov Click Opportunity Title to access opportunity synopsis Click Application to access application package Now let’s get to the same step using the NIH Guide… 15

16 Finding FOAs for Investigator–Initiated Research NIH Office of Extramural Research Parent Announcements for Unsolicited Applications

17 Screen shots of NIH Guide at Enter search string or advanced search Finding FOAs in NIH Guide for Grants & Contracts Enter search string or click Advanced Search NIH Guide for Grants & Contracts

18 Finding FOAs in NIH Guide for Grants & Contracts In Advanced Search screen, enter search parameters and click on Search button. Enter search parameters Click Search

19 Finding FOAs in NIH Guide for Grants & Contracts Review list of FOAs matching your criteria and find FOA of interest Click Announcement Number link to access FOA information

20 Announcement Notes Carefully read the entire announcement! Key dates: Release/Posted Date: package and instructions available for download; begin preparing application Application Submission/Receipt/Due Date: applications must be submitted by 5:00 p.m. local time Opening Date: systems begin accepting applications Expiration Date: announcement closed

21 Announcement Notes FOAs in the NIH Guide include button to download app from Grants.gov Click downloadVerify information Click Apply for Grant Electronically found within the NIH Guide announcement. Can also get to this screen by clicking Application from Grants.gov synopsis…

22 Download Package & Application Guide Download application instructions and Application Package Sign up for Agency updates to FOA

23 Application Guide Read and follow application guide instructions Agency-specific instructions are marked with the HHS logo

24 Prepare Application Prepare to Apply & Register Find Opportunity Prepare Application Submit, Track & View Submission Complete

25 SF 424 (R&R) Data Set NIH uses the SF 424 Research & Related (R&R) data set Owned and maintained by Grants.gov NIH applications include: Federal-wide (R&R) components NIH cannot build agency-specific business rules into federal-wide forms Agency-specific (PHS 398) components

26 SF 424 (R&R) Data Set SF 424 (R&R) Components include: SF 424 (R&R)—An application cover component Research & Related Project/Performance Site Location(s) Research & Related Other Project Information Research & Related Senior/Key Person Profile (Expanded) Research & Related Budget R&R Subaward Budget Attachment(s) Form Budget Information – Construction Programs Small Business Innovation Research (SBIR) & Small Business Technology Transfer (STTR) Information

27 NIH Agency-specific components NIH requires additional information for review of its biomedical research portfolio. NIH agency-specific components (titled PHS 398): PHS Cover Letter File PHS 398 Cover Page Supplement (supplements the R&R Cover) PHS 398 Modular Budget PHS 398 Research Plan PHS 398 Checklist PHS 398 Career Development Award Supplemental Form PHS Fellowship Supplemental Form PHS 398 Research Training Program Plan PHS 398 Training Budget PHS 398 Training Subaward Budget Attachment(s) Form

28 Grant Application Package Screen Make sure you have the correct application package. FOA information is automatically populated and not editable. Save the package locally. *Application Form Screen - Top* Mandatory Grants.gov fields highlighted yellow with red box.

29 Grant Application Package Screen Mandatory Documents must be completed prior to submission. *Application Form Screen - Bottom* Complete the SF 424 (R&R) form first – info from this form populates fields in other forms in the package. See application guide to determine which Optional Documents you need to include.

30 Ten Checks for Avoiding Common Errors 1. Does the DUNS number on the SF 424 (R&R) cover form match the DUNS number used for Grants.gov & Commons registrations?

31 Ten Checks for Avoiding Common Errors Primary site DUNS is required by NIH and is enforced by the eRA systems with a validation In ADOBE-FORMS-B1 application packages, the DUNS is no longer marked as required on the federal-wide Project/Performance Site Location(s) form

32 Ten Checks for Avoiding Common Errors 2. Did you provide correct Type of Submission (box #1), Federal Identifier (box #4), and Type of Application (box #8) information on the SF 424 (R&R) cover form? Use Application for first submission attempt Use Changed/Corrected when submitting again to correct eRA- identified errors/warnings

33 Ten Checks for Avoiding Common Errors If box 1=Application and box 8=New, then leave blank If box 1=Changed/Corrected and box 8=New, then enter previous Grants.gv tracking number Otherwise, use Institute and serial # of previous NIH grant/app (e.g., use CA from 1R01CA ) See Application Guide for definition of application types

Ten Checks for Avoiding Common Errors Type of Application (box 8) TermNotes NewAn application that is submitted for funding for the first time. (Type 1) RenewalPrevious years of funding for the project have elapsed. Competing for additional years of funding to continue original project. (Type 2) RevisionRequest for additional funds for a current award to expand the scope of work. Applicants should contact the awarding agency for advice on submitting any revision/supplement application. (Type 3) ResubmissionApplication previously reviewed. A revised or amended application that addresses reviewer feedback. (A1) ContinuationNIH does not use the SF 424 (R&R) for Continuation applications. (Type 5; progress reports for simplified non-competing (SNAP) applications are submitted directly to eRA Commons; for others, paper apps. are still submitted.)

35 Ten Checks for Avoiding Common Errors 3. Did you include the eRA Commons ID in the Credential field of the R&R Sr./Key Person Profile form for all PD/PIs? 4. If submitting a Multiple-PD/PI application, did you give all PIs the PD/PI role on the Sr./Key Person Profile form?

36 Ten Checks for Avoiding Common Errors Enter PI Commons Username eRA Commons username must be supplied in the Credential field For multiple PD/PI applications, select the PD/PI role for each PI and provide their eRA Commons username in the Credential field Enter PI Commons Username Select PD/PI role for each PI

37 Ten Checks for Avoiding Common Errors 5. Did you include Organization name for all Sr./Key listed on the R&R Sr./Key Person Profile (Expanded) form? Organization Name PD/PI Organization will auto-populate from SF 424 (R&R) cover if available. NIH requires the Organization name for all Sr./Key listed. Enter Organization Name

38 Ten Checks for Avoiding Common Errors 6. Did you include all required attachments? Whether an attachment is required is often based on how the applicant answers specific questions throughout the application Examples: Human Subjects = Yes, then Human Subjects section of the PHS 398 Research Plan required Vertebrate Animals = Yes, then Vertebrate Animals attachment is required More than one entry on the R&R Sr./Key Person Profile form with the role of “PD/PI,” then the Multiple PD/PI Leadership Plan attachment on the PHS 398 Research Plan form is required

39 Ten Checks for Avoiding Common Errors Annotated form sets available on the Resources page of the Applying Electronically website are a great resource for helping identify many conditional requirements. Annotated form sets:

40 Ten Checks for Avoiding Common Errors 7. Are all your attachments in PDF format? Use simple PDF-formatted files Do not use Portfolio or similar feature to bundle multiple files into a single PDF Disable security features such as password protection Keep file names to 50 characters or less and use only letters, numbers and underscore (_) Do not include headers or footers Section headings as part of the text (e.g., Specific Aims, Background & Significance) are encouraged Follow guidelines for fonts and margins Avoid 2-column and “landscape” format PDF Guidelines:

41 Ten Checks for Avoiding Common Errors 8. Did you follow the page limits specified in the FOA and application guide? Find page limits in: FOA text Application guide page limit table Application guide form field instructions (Page limit table from Application Guide)

42 Ten Checks for Avoiding Common Errors 9. Did you include effort > 0 for all Sr./Key personnel listed on the R&R Budget form? Use either calendar months or a combination of academic and summer months PD/PI must have effort >0 for every period Include effort > zero for all Sr./Key listed

43 Ten Checks for Avoiding Common Errors 10. Did you follow all special instructions noted in Section IV. Application and Submission Information of the announcement? When the application guide and FOA instructions differ, the FOA wins FOA-specific requirements are not typically system-enforced Applications that do not comply with the instructions may be delayed or not accepted for review

44 Program-specific Considerations Special considerations for special programs Individual National Research Service Award (NRSA) Fellowships (F) Research Career Development Award Program (Ks, except K12) Institutional Training (Ts & Ds) and Institutional Career Development (K12)

45 Fellowship (F) Applications Fellowship (F) applications Fellowship-specific Application Guide Designate Sponsor on the R&R Sr./Key Person Profile (Expanded) form Select Role of “Other”, then indicate “Sponsor” in Other Role category Complete PHS Fellowship Supplemental Form, including new Sponsor(s) and Co-Sponsor(s) section PHS Cover Letter form is required Include list of referees that will submit reference letters through Commons

46 Career Development (K) Applications Research Career Development Award Program (Ks, except K12) applications Supplemental instructions for Career Development applications added to general Application Guide (Part I, Section 7) Complete PHS 398 Career Development Award Supplemental form PHS Cover Letter form is fequired for mentored Ks (K01, K07, K08, K18, K22, K23, K25, K99) Include list of referees that will submit reference letters through Commons

47 Career Development (K) Applications New K page limits for due dates on/after January 7, 2011 Mentoring Plan - 6 pages Statements by Mentor, Co-Mentors, Consultants, Contributors - 6 pages Description of Institutional Environment - 1 page Institutional Commitment to Candidate's Research Career Development - 1 page NIH Guide Notice: NOT-OD

48 Training Applications Training (Ts & Ds) and Institutional Career Development (K12) Program applications Supplemental instructions for Training applications added to general Application Guide (Part I, Section 8) Depending on FOA, one of three application packages is used; vary by budget requirements R&R Budget (only) PHS 398 Training Budget (only) R&R Budget and PHS 398 Training Budget Complete PHS 398 Research Training Program Plan Data Tables – user defined bookmarks included in the attachment will be pulled into application image

49 Submit, Track & View Prepare to Apply & Register Find Opportunity Prepare Application Submit, Track & View Submission Complete

50 AOR - Submit Application Check Package for Errors only checks a subset of Grants.gov errors You must SUBMIT the application for it to be checked against NIH application instructions. NIH errors/warnings will be displayed in the eRA Commons. Save & Submit button will not become active until application is saved and mandatory information is completed.

51 Enter your Grants.gov username and password – you must be fully registered to successfully submit. Only the AOR can submit application! AOR - Submit Application

52 AOR - Submit Application Click Sign and Submit Application button to record electronic signature and initiate submission process to Grants.gov.

53 AOR - Submit Application Print/Save your Confirmation screen info Grants.gov Tracking # Date/Time Stamp - due 5 p.m. local time of the applicant org. on submission deadline date

54 On-time Submission Error-free submission must be accepted by Grants.gov with a time stamp on or before 5:00 p.m. local time (of submitting organization) on due date NIH recommends submitting early (days, not minutes) to have time to address system-identified errors or problems found during the application viewing window All Changed/Corrected submissions must be made by the due date/time NIH’s late policy does not allow for error corrections after the deadline

55 Updated Late Policy Updated NIH Policy on Late Submission of Grant Applications Consolidates previous notices (NOT-OD and NOT- OD ) Reflects other policy changes (e.g., the elimination of the error-correction window) Provides additional guidance Specifically indicates that failure to complete required registrations by the deadline and the need to correct errors/warnings are not acceptable reasons for late submissions Permission to submit late not given in advance 55 NIH Guide Notice: NOT-OD

56 eRA Commons Signing Officials (SOs) Principal Investigators (PIs) Delegated Assistants (ASSTs) Track Application Status Grants.gov Authorized Organization Representatives (AORs)

57 Track Status - Grants.gov Notifications AOR receives Grants.gov s Receipt Grants.gov verifying receipt of application Validation Grants.gov verifying successful submission to Grants.gov OR rejection due to errors Transmission to Agency sent once agency retrieves submission sent when agency tracking number assigned

58 Track Status – Grants.gov Validations Grants.gov Error Checking Grants.gov mandatory fields completed Mandatory documents moved to the Mandatory Documents for Submission box and completed DUNS# on application matches DUNS# in organization’s Grants.gov registration Attachments are Virus-free Have file names of 50 characters or less Have file names with no spaces or special characters ( -, &, *, %, /, #, \); underscore (_) is OK

59 Track Status – Grants.gov (AOR) Grants.gov application status

60 Track Status – eRA Commons Commons Status is an integral part of electronic application submission Applications are picked up by eRA Commons and checked against application guide and opportunity instructions Processing result available in eRA Commons Status to SOs, PIs and delegated assistants notifications sent

61 Track Status- eRA Commons Notifications eRA s are sent to the AOR/SO, PD/PI and contact s listed on SF 424 (R&R) form Validation complete, check assembled application Validation complete, check assembled application – Warnings only Action required – Errors and/or Warnings Action required – Missing or invalid eRA Commons Username (only sent to AOR/SO) Action required – System Error SO has refused electronic application (rejected) NIH has auto-verified the application (after 2-day viewing window)

62 Accessing eRA Commons Go to: Enter your Username and Password Username Password

63 PI Admin – Delegate Status PD/PIs can Delegate Status viewing privileges Provides access to PI’s Status information including the ability to check for application submission errors/warnings and to view the assembled application image DOES NOT provide access to application summary statement or priority score Delegation can be made to any eRA Commons user at the PI’s institution with the Assistant (ASST) role

64 Track Status in Commons – PD/PI Select Recent/Pending eSubmissions Or provide Grants.gov tracking number from notification

65 Track Status in eRA Commons – PD/PI Grants.gov tracking # and date are displayed followed by the list of errors/warnings for each submission attempt Indicates eSubmission Error Grants.gov Tracking #

66 Track Status in eRA Commons Errors stop application processing and must be corrected before the deadline Warnings do not stop application submission and are corrected at the discretion of the applicant before the deadline Helpful Links Avoiding Common Errors page: Full list of Commons Validations:

67 Correcting eSub Errors/Warnings To correct errors/warnings in an application submission: Make needed corrections to the local application forms Check Changed/Corrected in the Type of Submission field located in box #1 of the SF 424 (R&R) form Federal Identifier on SF 424 (R&R) cover (box #4) is a required field when Changed/Corrected is selected If box #8=New, include original Grants.gov tracking number Otherwise, continue to use the Institute/Center and serial number from original application/grant number (ex. CA987654) Include cover letter if after submission deadline Submit the entire Changed/Corrected application back through Grants.gov before the deadline Track submission through to Commons NOTE: Reviewers do not see applicant errors/warnings.

68 View Application Image Once an error-free application is received, the eRA system will: Assemble the grant application image Insert headers (PI name) & footers (page numbers) on all pages Generate Table of Contents and bookmark important sections Post the assembled application image in the PI’s eRA Commons account

69 Application Viewing Window Applicants have two (2) business days to view the assembled application before it automatically moves forward to NIH staff for further processing SO can Reject application within viewing window and submit a Changed/Corrected application prior to the due date If you can’t VIEW it, we can’t REVIEW it!

70 Status – View Application Image View Appendices and Cover Letter Follow e-Application link to view assembled application image Follow link to detailed status info Status is Pending Verification

71 Status – e-Application TIP: Carefully review the entire application. This is your first chance to view/print the same application image that will be used by Reviewers!

72 Reject Application (SO) Must have SO role Select Recent/ Pending eSubmissions Click Search Enter Search Criteria PIs: If the application image in the eRA Commons does not properly reflect the submitted material, work with your SO to reject the application!

73 Reject Application (SO) Select Reject eApplication Enter comment to be sent with notification Click Reject

74 Submission Complete! Prepare to Apply & Register Find Opportunity Prepare Application Submit, Track, & View Submission Complete

75 Submission Complete! If no action is taken during the two business day viewing window, the application automatically moves forward to NIH for further processing.

76 eSub Odds & Ends

77 Trouble submitting due to system issues? When Grants.gov or eRA system issues threaten your on-time submission… Contact appropriate support to try to get resolution If working with Grants.gov, contact eRA Help Desk to document issue and steps taken toward resolution oIf verified system issue, this documentation can be used in place of tracking # and time stamp as proof of "on-time" submission oDocument your issues and corrective actions, including support ticket numbers, in cover letter If eRA Help Desk confirms a system issue, your application will not be considered late as long as you work diligently with the Help Desk to resolve problems as quickly as possible

78 NIH Contingency Plans Contingency plans Address large-scale, extended system issues on submission deadline dates Individual issues, issues affecting small subsets of applicants, or issues lasting less than a half business day handled case-by-case Sample actions: Extending submission deadline Communicated through: Alert on Commons log in screen Notice in NIH Guide for Grants & Contracts: Commons listservs: Applying Electronically website:

79 Reference Letters Some NIH grant programs require the submission of reference letters in addition to the grant application (e.g., Mentored Career Development program) Letters are NOT part of the electronic application through Grants.gov Submitted directly by the referee through eRA Commons Commons registration not required to submit reference letter Letters can be submitted in advance of application submission Letters are joined with the electronic application within the eRA system once the application submission process is complete Reference letters are due by the application submission deadline Applications missing the required letters may be delayed in the review process or not accepted at all Applicants can track the submission of reference letters in the Commons, but cannot view the actual letter Information about the reference letter process can be found in each applicable FOA and within the application guide.

80 More Policy & Process Updates Keep an eye on the NIH Guide for Grants and Contracts for policy and process updates. Subscribe for weekly s of new Guide postings:

81 Post-submission Application Materials NIH will only accept post-submission grant application materials resulting from unforeseen administrative issues for most applications See Guide Notice for details on acceptable and unacceptable material, exceptions, and page limits When exceptions do apply, materials must be received at least 30 days prior to the peer review meeting and must be sent by (or with the explicit concurrence of) the AOR 81 NIH Guide Notice: NOT-OD

82 New Rules for Resubmissions NIH now allows only a single Resubmission (A1) for most applications NIH Guide Notice: NOT-OD Applicants must submit their Resubmission application (A1) within thirty-seven (37) months of the initial New, Renewal, or Revision application due date NIH Guide Notice: NOT-OD

83 Appendix Policy & “Overstuffed” Applications Applicants must follow application guide and announcement instructions regarding appropriate appendix materials Applicants should not use the Appendix section to circumvent page limits In particularly egregious cases NIH has the authority to withdraw the application from review or consideration for funding NIH Guide Notice: NOT-OD

84 Summary of Related Policy Changes Effective Date Policy Change and Guide Notice 05/07/11ADOBE-FORMS-B1 for all electronic applications Posted: 03/29/2011 Change in Policy on the Submission of Plans for Instruction in the Responsible Conduct of Research (K applications) Posted: 02/11/2011 Change in Policy on the Submission of Plans for Instruction in the Responsible Conduct of Research (T and D applications) /25/11End of two-day error correction window 01/25/11ADOBE-FORMS-B1 required for F, K, T, D applications 01/25/11Time limit (37 months) for NIH Resubmission applications Posted: 01/20/2011 Change in Policy on the Submission of Letters of Reference

85 Summary of Policy Changes Effective Date Policy Change and Guide Notice Posted: 01/13/2011 Updated late policy html 01/07/11End of A2 application submissions html 01/07/11New page limits for Ks html Posted: 11/9/2010 New FOA format html 09/25/10New policy on post-submission application materials html html

86 Resources Support, FAQs, Websites

87 Grants.gov Support Resources Grants.gov Contact Center Assistance with: Grants.gov registration; form behavior & navigation; issues submitting to Grants.gov site Phone: Help Page Resources, FAQs, Troubleshooting Tips Download Software Page

88 NIH & eRA Commons Resources eRA Commons Help Desk Assistance with: eRA Commons registration, eRA system validations Create ticket on Web: Phone: Toll-free: TTY: Business hours Mon.-Fri., 7 a.m.-8 p.m. E.T.

89 NIH & eRA Commons Resources Websites: eRA Commons: Electronic Research Administration: Applying Electronically: NIH About Grants:

90 Questions