From your ideas… 1 … into our systems… …to advance medical discovery. Interacting Electronically with NIH Megan Columbus NIH Program Manager for Electronic Receipt of Grant Applications Scarlett Gibb eRA Customer Relationship Manager

2 Electronic Interaction Points Learn About Grants at NIH Find Opportunities Submit Application Check Submission Status Download App Package View Assembled Application Image Check Review Assignment Submit Pre-Award Information Check Review Outcome Prepare/Submit Post-Award Reports Closeout Grants NIH Guide NIH Grant Web site Grants.gov eRA Commons

3 Learn About Grants eRA, Commons, eSubmission POLICY NIH GUIDE FORMS & INSTRUCTIONS, SUBMISSION DATES GLOSSARY, FAQS INITIATIVES GET CONECTED BASICS

4 Electronic Submission Required! Electronic submission via Grants.gov is now required for ALL competing grant applications with the exception of Complex, Multi-project applications (Project/Centers)* *These grant mechanisms will continue to use the paper PHS398 application process until a transition to electronic submission is scheduled, announced and implemented.

5 eSubmission Process Prepare to Apply & Register Find Opportunity and Download Application Package Submit, Track and View Application Prepare Application Submission Complete!

6 Two Systems Working Together Grants.gov – the Federal government’s single online portal to find and apply for Federal grant funding –Used by all 26 Federal grant-making agencies eRA Commons – electronic Research Administration system that allows applicants, grantees and Federal staff to access, share and transmit information related to their applications and grants –Used by NIH and a few other HHS components IMPORTANT: Each system has its own registration and validations requirements

7 Registration Grants.gov Applicant Organizations only Designate E-Business Point of Contact (E-Biz P - 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.

8 Registration Tips for Success: 1.Start early! The registration process can take up to 4 weeks (8 weeks or more for new or foreign businesses) 2.Register for Grants.gov & Commons simultaneously once DUNS# is obtained 3.Update CCR information yearly to keep Grants.gov credentials active 4.Do not combine SO and PI roles on single Commons account 5.If PD/PI has a Commons account, affiliate them to your organization rather than creating new account 6.PIs should update their Commons profile prior to submitting (degree info used to determine Early Stage Investigator eligibility)

9 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!

10 Obtain Software Grants.gov Download Software Web Page: Adobe Reader Only specific Adobe Reader versions are compatible with Grants.gov forms PDF conversion program Attachments must be converted to PDF

11 eSubmission Process Prepare to Apply & Register Find Opportunity and Download Application Package Submit, Track and View Application Prepare Application Submission Complete!

12 Find Opportunity & Download Package NIH posts Funding Opportunity Announcements (FOAs) on: –NIH Guide for Grants and Contracts Announcements include button to download package and instructions from Grants.gov –Grants.gov

13 Investigator–Initiated Research All applications must be submitted in response to a Funding Opportunity Announcement (FOA) –Applicants can submit for funding opportunities focused on specific programs/areas of science OR in response to a general “parent” announcement –Applicants MUST use the application package specific to the FOA that they choose

14 Parent FOAs NIH Office of Extramural Research Parent Announcements for Unsolicited Applications

15 Finding FOAs in NIH Guide NIH Guide for Grants & Contracts Enter search string or click Advanced Search

16 Finding FOAs in NIH Guide Enter search parameters Click Search

17 Finding FOAs in NIH Guide Review list of FOAs matching your criteria and find FOA of interest Click Announcement Number link to access FOA information

18 Announcement Read and follow announcement instructions Pay special attention to Section IV. Application and Submission Information –Includes any FOA-specific submission instructions –Instructions in FOA trump instructions in the application guide

19 Announcement Notes Pay attention to Key dates: –Release/Posted Date: package and instructions available for download –Opening Date: application can be submitted –Expiration Date: announcement closed

20 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.

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

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

23 eSubmission Process Prepare to Apply Find Opportunity and Download Application Package Submit Track and View Appilcation Prepare Application Submission Complete!

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

25 Grant Application Package Screen Mandatory Documents must be completed prior to submission. *Application Form Screen - Bottom* Complete the SF424 (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.

Completing the Application 26 Tips for Success: Follow FOA-specific guidelines (e.g., special attachments, specific section headings) Follow application guide requirements Follow guidelines for fonts, margins Do not include headers or footers - Section headings as part of the text (i.e., Specific Aims, Background & Significance) are encouraged Avoid 2-column format for text Avoid “landscape” format

27 Final Application Check Avoid Grants.gov & eRA Commons Errors: –SF424 (R&R) cover Does the DUNS number on your application match the DUNS used for Grants.gov & Commons registration? Did you include the Contact address? Did you provide correct Type of Application, Federal Identifier, and Type of Submission information? –Sr/Key Person Profile Did you include Commons ID in Credential field for all PD/PIs? Did you include Organization name for all Sr/Key?

28 Final Application Check Avoid Grants.gov & eRA Commons Errors (cont.): –Did you use the correct Budget form? –Did you include effort > 0 for all Sr/Key listed on the R&R Budget form? –Did you include all required attachments? –Are all your attachments in PDF format? –Are all attachment names 50 characters or less and use only letters, numbers and underscore (_)?

29 eSubmission Process Prepare to Apply Find Opportunity and Download Application Package Submit, Track & View Application Prepare Application Submission Complete!

30 AOR - Submit Application Check Package for Errors only checks Grants.gov errors. Save & Submit button will not become active until: All fields marked as mandatory on the forms are completed All Mandatory Documents are moved to Mandatory Documents for Submission box and completed The application is Saved You MUST submit the application for it to go through the NIH validation process. NIH errors will be shown in the eRA Commons

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

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

33 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

On-time Submission –All registrations must be completed prior to initial submission –Submission must be accepted by Grants.gov with a timestamp on or before 5:00 p.m. local time of submitting organization on submission deadline date –Errors/Warnings must be corrected within the error correction window

35 Track Application AORs track application status at Grants.gov Signing Officials(SOs), Principal Investigators (PIs) and Assistants (ASSTs) track appilcation status in the eRA Commons

Track – Grants.gov (AOR) Applicant interface Grants.gov application status

37 You’re not done yet! Signing Officials (SOs), Principal Investigators (PIs) and Assistants (ASSTs) track application status in the eRA Commons.

Track Your Application Applications are picked up by eRA Commons and checked against application and opportunity instructions Forms are owned by Grants.gov and used by many agencies, so NIH cannot build agency-specific business rules into the formProcessing result available in eRA Commons Status Processing result available in eRA Commons Status notifications sent to AOR/SO, PD/PI and contact s listed on the SF424 (R&R) form

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

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

41 Status – eSub Errors/Warnings Indicates eSubmission Error Grants.gov Tracking # Grants.gov tracking # and date are displayed followed by the list of errors/warnings for each submission attempt

42 Status – eSub Errors/Warnings Errors stop application processing and must be corrected Warnings do not stop application submission and are corrected at the discretion of the applicant Helpful Links Avoiding Common Errors page: Full list of Commons Validations

43 Error Correction Window NIH currently allows applicants to correct errors/warnings during the temporary “Error Correction Window” -Standard window: 2 business days after the submission deadline (temporarily extended to 5 days through May 2010) -Initial submission made “on time” -All registrations completed before deadline -Proof of “on time” submission and description of all changes documented in Cover Letter AOR is expected to enforce that appilcation changes are restricted to those needed to fix indentified errors/warnings. NIH may reject any application that includes additional changes.

44 Correcting eRA Errors/Warnings Make changes to address error/warning messages in local copy of application 1.Select Changed/Corrected on SF424 (R&R) cover (box #1)  Federal Identifier on SF424 (R&R) cover (box #4) is a required field when Changed/Corrected is selected If New is selected in box #8, use Grants.gov tracking number for original submission Otherwise, continue to use the Institute/Center and serial number from original grant award (ex. CA123456) 2.Include cover letter if after submission deadline 3.AOR must submit the entire changed/corrected application to Grants.gov 4.Track submission through to Commons NOTE: Reviewers do not see applicant errors/warnings.

45 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

46 Application Viewing Window Applicants have two (2) business days to view the assembled application before it automatically moves forward to NIH for further processing SO can Reject application within viewing window to address Warnings (if within error correction window) or to address a system issue affecting the application image –If Rejected after deadline for any other reason, application is subject to late policy –PI will receive notification if SO rejects application If you can’t VIEW it, we can’t REVIEW it!

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

48 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!

49 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!

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

51 eSubmission Process Prepare to Apply Find Opportunity and Download Application Package Submit, Track & View Application Prepare Application Submission Complete!

52 Submission Complete! If no action is taken during the two business day viewing window, the application automatically moves forward to NIH for further processing Any subsequent application changes are approved through and at the discretion of the Scientific Review Officer in the form of addenda

53 Finding Help Applicant Resources

54 Finding Help: Web Site Links Links to Applicant Resources –NIH eSubmission Website: –Grants Web site: –electronic Research Administration: –eRA Commons:

55 Finding Help Grants.gov: For help with the Grants.gov registration process, downloading forms, form behavior or with technical aspects of submitting through the Grants.gov system: –Check the Grants.gov Website: –Grants.gov Contact Center Contact Center Phone: Business Hours 24 hours/day; 7 days/week (closed on Federal Holidays) eRA Commons: For help with eRA Commons registration or system validations after submission through Grants.gov: –Check the eRA Commons website: –eRA Commons Help Desk Web support: Phone: Toll Free: TTY: Business hours M-F, 7am-8pm ET Grants Info: For help with grant policy, application content requirements and other general inquiries: –Review the Application Instruction Guide –Review the FOA –Grants Info: Phone:

56 Grant Administration in eRA Commons Check Review Assignment Submit Pre-award Information Check Review Outcome Prepare/Submit Post-award Reports Closeout Grants eRA Commons My application is submitted… …now what? Additional eRA Commons features Update Personal Profile and Institutional Profile Information

57 eRA Commons Applications: –Profiles (Personal and Institutional) –Application Tracking –Grant Status –Just In Time (JIT) –Electronic Streamlined Non-competing Award Process (eSNAP) –Closeout –No-cost Extension (NCE) –Financial Status Report (FSR) –Internet Assisted Review (IAR) –xTrain –Financial Conflict of Interest (FCOI) –My BIB / My NCBI integration

58 Institutional Profile (IPF) The Institutional Profile –Contains information necessary to facilitate processing & review of applications submitted by an institution –Is a central repository of information for registered organizations –Is designed so each organization’s Signing Official (SO) establishes & maintains his or her organization’s profile data It includes information such as: –Preferred institution name & contact information –Signing Official’s name, , & phone number –Institutional DUNS number –Institutional Assurances – addresses to receive Notice of Award and other notificationsNotice of Award

59 Personal Profile (PPF) Personal Profile maintenance –You are responsible for keeping your information accurate & up-to-date. –Very few staff members at NIH have access to change PPF information (emergencies only). –Commons will require a change of password every 90 days for security reasons. TIP: Always keep your address up-to-date. addresses are used to retrieve forgotten passwords and as the primary source of communicating grants-related information.

60 Uses of PPF Information … display to the reviewer the status of eligibility for Continuous Submission … determine whether a PI is eligible for Early Stage Investigator (ESI) status … verify information submitted in grant applications … populate specific forms (Trainee Appointment, etc.) … allow for automatic population of publications in National Library of Medicine systems … contact you via Agency notifications … used in aggregate reporting …monitor submission of reference letters

61 Accommodating Your Work Flow Commons allows many functions to be delegated to other users Delegate PI –Delegation can be made to any other eRA Commons user at the institution –Provides ability to complete eSNAP information for the PI’s grants (cannot Route or Recall) Delegate PPF Edit –Delegation can be made to any other eRA Commons user at the institution –Provides ability to edit Personal Profile (PPF)

62 Accommodating Your Work Flow Delegate Status –Delegation can be made to any eRA Commons user at the PI’s institution with the Assistant (ASST) role –Provides access to PI’s Status information, including the ability to check for submission errors/warnings and to view the assembled application image –DOES NOT provide access to application summary statement or priority score Delegate xTrain Authority –Delegation can be made to any eRA Commons user at the PI’s institution with the Assistant (ASST) role –Provides same xTrain authority as the PI, except the ability to Submit appointments to the Agency

63 Delegation to PI Signing Official (SO) can “Delegate Submit” authority to a PI –Allows a PI to submit his or her own eSNAP information to Agency Delegate Submit

64 Tracking Application Status as a PI Note: There is a separate SO-tailored view of the Status page.

65 Status Hit List Click App ID for detailed Status info STATUS is your LINK to the Action! Action links: JIT, eSNAP, Closeout, NCE (SO only), Reject eApplication (SO only)

66 Track Assignment Info. in Status Details Primary Institute Assignment Study Section Assignment Key Contact Information

67 Track Review Outcome Only the PI can view Summary Statement, Priority Score and Percentile information.

68 Just In Time Submission (JIT) Allows PIs, AOs, & SOs to prepare and SOs to submit additional grant application information requested by NIH prior to an award decision –Other Support, IRB and/or IACUC Approval Dates, Human Subjects Education info Not an indication that application will be awarded Wait for a request from NIH to submit the information –System-generated or contact from the Grants Management Specialist (GMS) You may now submit JITs piece by piece!

69 Click on the JIT link in the Action column of the Status hit list. Just In Time

70 eSNAP Electronic Streamlined Non-competing Award Process (eSNAP) Electronic submission of annual SNAP Progress Reports –Most non-competing grants at NIH are streamlined SO can enable the organization to submit eSNAPs Benefits: –Submission deadline is 45 days prior to start date instead of 60 days –Reduces duplicate data entry

71 eSNAP Electronic Streamlined Non-competing Award Process (eSNAP) PI or PI Delegate can initiate the process, upload progress report, and enter the administrative data eSNAP can be routed to staff for approval SO submits the completed eSNAP to NIH –SO can delegate submit privileges to PI(s)

72 eSNAP Begin the eSNAP either from the Action column of the Status Hit List or the eSNAP item on the menu bar.

73 eSNAP Hit List PI hit list shows all grants and applications with the Grant Number of eSNAP-eligible grants hyperlinked.

74 My BIB Publications in eSNAP Upload Science screen shows My BIB publications that can be associated with an eSNAP report. For more My BIB & My NCBI info:

My BIB / My NCBI Integration From the new Awards View in My NCBI, eRA Commons users can: –See whether their publications are compliant with the NIH Public Access Policy –Start the manuscript submission process –Associate their NIH extramural grants awards with their publications –Designate delegates to manage their bibliography via My NCBI Note: The Awards View is only available to Commons users with active grants in their portfolios who have linked their My NCBI account with their Commons account.

76 Financial Status Report Financial Status Report (FSR) Statement of expenditures usually due within 90 days from end of budget period or project period Schedule for submitting FSRs is normally specified in the Notice of Grant Award Can be searched by individual grant number, FSRs for the institution or status of the FSR Must have an account with the FSR role to create/submit the FSR

77 FSR Search Screen To view Financial Status Report status code definitions, visit:

78 Financial Conflict of Interest (FCOI) FCOI Institutional Functionality Allows grantee institutions to: –Initiate and prepare a FCOI notification Multiple FCOI officials and delegates can access and edit a notification while in Work In Progress (WIP) status –Submit the FCOI notification and supporting documents electronically to Agency Can provide comments at time of submission that are included in notification to Agency –Search and View FCOI notifications previously submitted through Commons Does not provide visibility to any notifications previously submitted on paper –Edit or rescind submitted notifications (requires Agency involvement) –Access history of actions

79 Commons FCOI & Internal FCOI Commons FCOI integration with internal FCOI tracking system Commons FCOI and Internal FCOI systems will share information once daily Internal FCOI users can request additional information and rescind notifications –Notification to Institution made from Internal FCOI system and also is reflected in Commons FCOI history

80 FCOI Flexible Account Admin Commons account must have FCOI role to submit FCOI notifications to Agency –Only SOs can add this role to an account –FCOI role can be added to multiple accounts at institution’s discretion Ability to prepare and/or view FCOI notifications can be delegated, but not ability to submit to Agency –FCOI ASST –FCOI View-only

81 xTrain Allows users to electronically process the required paperwork associated with awarded training grants Grantee institution staff can use xTrain to: –Create, route and submit Appointments, Re- Appointments, Amendments and Termination Notices –Track the status and timing of training actions NIH’s goal is to mandate xTrain use by Jan Gain experience now!

82 xTrain – New Commons Roles xTrain introduces two new eRA Commons roles Trainee –Person appointed to training grant –Currently, account set-up done through xTrain Business Official (BO) –Has signature or other authority related to administering training grants –Authorized to submit Termination Notices on behalf of the institution

83 xTrain

84 No-cost Extension No-cost Extension (NCE) Electronically submit a notification to exercise one-time authority to extend without funds the final budget period of a project period of a grant NCE link appears 90 days before the end of the project period SO (only) can extend project period by 6, 9 or 12 months notification sent to NIH Grants Management staff when SO processes the extension

85 No-cost Extension Link Status Result - General Search screen shows grants that may be extended via a No-cost Extension (see Extension hyperlink in Action column).

86 Closeout Electronically submit required Closeout documents for grants in Closeout status NIH GM Specialist must mark the grant “ready for close out” for link to appear in Commons –contact assigned GMS if records are not appearing Required Closeout items include: –Financial Status Report (FSR) -Final Progress Report -Final Invention Statement

87 Closeout Link Status Result - Closeout Search screen shows grants that are Closed or Requires Closeout.

88 Finding Help Applicant Resources

89 Finding Help: Web Site Links Links to Applicant & Grantee Resources –NIH Grants Web site: –Electronic Research Administration: –eRA Commons:

90 Finding Help Grants.gov: For help with the Grants.gov registration process, downloading forms, form behavior or with technical aspects of submitting through the Grants.gov system: –Check the Grants.gov Web site: –Grants.gov Contact Center Contact Center Phone: Business Hours: 24 hours/day; 7 days/week (closed on Federal Holidays) eRA Commons: For help with eRA Commons registration or system validations after submission through Grants.gov: –Check the eRA Commons Web site: –eRA Commons Help Desk Web support: Phone: Toll Free: TTY: Business hours M-F, 7am-8pm ET Grants Info: For help with grant policy, application content requirements and other general inquiries: –Review the Application Instruction Guide –Review the FOA –Grants Info Phone:

91 Thank You!